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Our analysis showed that 53% of all MDD trials in the last 25 years were successful. US trials had a higher success rate than non-US trials (58% vs 33%). Before 1995, the overall success rate was 55%, compared to 50% for trials in 1995 or later, and, in general, 6-week trials had a higher success rate than 8-week trials (55% vs 42%).

Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stich.

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中国瓣膜行业几点发展趋势的探.docx,目 录 TOC \o "1-3" \h \z \u 一、我国心脏瓣膜行业现状:治疗需求大,处于快速发展基点 5 我国心脏瓣膜行业特点 6 特点 1:患者群体很大,且大多数治疗需求没有被满足 6 特点 2:手术主要集中在大医院 8 特点 3:中国患者患病结构特殊,过去风心病患者较多 9 行业 ...
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Sep 18, 2019 · Based on these promising results, the PASCAL system gained CE mark in early 2019. The pivotal CLASP IID/F randomized trial has begun enrolment, and will compare the efficacy and safety of PASCAL vs. MitraClip in patients with significant DMR or FMR, using a non-inferiority study design. Evidence From Randomized Trials

The CLASP IID/IIF clinical trial studies the PASCAL system, a device designed to repair the mitral valve with no open heart surgery. This trial is meant for patients with mitral regurgitation who are high-risk candidates for open heart surgery. Talk to your doctor to determine if this trial is right for you. Aug 13, 2020 · A total of 120 patients (88 Mitraclip XTR vs. 32 PASCAL recipients) treated in a single center were included. Although the patients in the PASCAL group exhibited higher baseline TR grades, no differences in procedural success were found between groups (86.4% in the MitraClip XTR group vs. 90.6% in the PASCAL group, p=0.75).

This study evaluates candidacy for surgical mitral valve repair of recurrent mitral regurgitation after failed MitraClip implantation.
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Oct 22, 2020 · LONDON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Information Services Group (Nasdaq: III), a leading global technology research and advisory firm, today announced the Crown Commercial Service (CCS) has awarded ISG a place on the UK Government’s latest G-Cloud framework, G-Cloud 12.

At 2 y, the use of MitraClip reduced the annualized rate of hospitalizations for HF (35.8% vs. 67.9% per patient-year, P<0.001) and led to a survival-benefit (29.1% vs. 46.1% deaths from any cause, P<0.001). The NNT to prevent one hospitalization in 2 y was 3.1, 5.9 to prevent one death respectively.

The primary effectiveness endpoint, HF hospitalization at 24 months for MitraClip + GDMT vs. GDMT, was 35.8% vs. 67.9% (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.40-0.70, p < 0.001). The primary safety endpoint, freedom from device-related complications at 12 months, was 96.6% for MitraClip (p < 0.001) Jul 02, 2020 · This resulted in the grant of a final injunction in the form suggested by Abbott, which only contained a very limited carve out permitting the use of PASCAL in cases where implantation with Abbott’s device, MitraClip, had already been unsuccessful.

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Pascal Meier1,2 Olaf Franzen,3 Alexandra J Lansky2. ... The MitraClip is a promising percutaneous alternative to surgical ... (7.4 vs 4.4 events per 100 patient-years ... But a considerable number of patients are not eligible for a MitraClip for anatomical reasons. The Pascal system uses a spacer, a device that fills the space between the leaflets, or doors, of the ...

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Although the patients in the PASCAL group exhibited higher baseline TR grades, no differences in procedural success were found between groups (86.4% in the MitraClip XTR group vs. 90.6% in the PASCAL group, p=0.75). SLDA was observed in 10/88 (11%) patients in the MitraClip XTR group and in 2/32 (6%) patients in the PASCAL group (p = 0.5). Thus ...Transcatheter mitral valve leaflet repair with PASCAL system: the role of echocardiography The Results of the ISCHEMIA trial with Dr Leslee Shaw Speckle Tracking-Basics Evaluation

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MitraClip Carillon Cardioband Mitralign Pascal >1,000 ≈75 >60,000. Severe FMR –Med Rx vs. MitraClip MitraFR and COAPT. Courtesy: M. Mack; TCT 2018 The MitraClip group also showed a significant reduction in all-cause mortality (HR 0.62; 95 CI 0.46–0.82; P < 0.001), with a NNT of 5.9, as well as improvements in quality of life, NYHA functional class, and functional MitraClip Edge to Edge Repair for FMR –the COAPT Trial ... (ischemic vs. non-ischemic) and site. COAPT Trial ... Pascal •Annuloplasty Cardioband Millipede Amend

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Eligible participants will be randomized to have the PASCAL System and the other group will receive the FDA-approved MitraClip System. The PASCAL System and the MitraClip System are designed to reduce the amount of mitral regurgitation without the need for surgery (less invasive).

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Edwards PASCAL transcatheter valve repair system pivotal clinical trial This study seeks to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System vs. Abbott MitraClip in patients with mitral regurgitation (MR). MR is when blood moves backward through the mitral valve each time the left heart ventricle ...

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You are about to leave for a 3rd party website. The "Yes" link below will take you out of the Abbott Laboratories family of websites. Links which take you out of Abbott Laboratories worldwide web sites are not under the control of Abbott Laboratories, and Abbott Laboratories is not responsible for the contents of any such site or any further links from such site. The impact of residual mitral regurgitation after mitraclip therapy in functional mitral regurgitation. Eur J Heart Fail. 2020. doi: 10.1002/ejhf.1774 Lim DS, Kar S, Spargias K, et al. Transcatheter valve repair for patients with mitral regurgitation: 30-day results of the CLASP study.

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Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral ...

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Mitraclip • Cardioband • TMV replacement ... Edwards PASCAL Mitral Repair System presented by Fabian Praz, The Mitral Valve Meeting, Zurich Feb 2017 ...

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Annual Scientific Report 2013 Annual Scientific Report 2013 Published by: IDIBAPS Rosselló, Barcelona Editorial Board Pastora Martínez, Managing Director Laura González, Managing Director 0 20 40 60 80 100 EVEREST II: 279 pts with 3+/4+ MR randomized 2:1 to MitraClip vs. Surgical Repair Primary Endpoints (per protocol cohort) 0 20 40 60 9.6% Device Group, n=136 vs. surgical MV repair or replacement. Results showed, at five years, increased safety of the percutaneous approach (15.0% major adverse events in MitraClip group vs. 48.0% in surgical group), and no difference in mortality (18.8% vs. 21.0%). Furthermore, a stable MR reduction and positive LV remodeling following MitraClip implant were seen.

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Exercising for health and longevity vs peak performance: different regimens for different goals. O'Keefe, James H., Franklin, Barry and Lavie, Carl J. (2014). Exercising for health and longevity vs peak performance: different regimens for different goals. Mayo Clinic Proceedings, 89 (9), 1171-1175. doi: 10.1016/j.mayocp.2014.07.007 潘文志 周达新 葛均波复旦大学附属中山医院乾坤空落落,岁月去堂堂。2020年稍纵即逝,又到年终盘点时间。由于新冠疫情,整个世界仿佛被按下慢进键,经导管瓣膜治疗也不例外。 MitraClip’s superiority also extended to all prespecified secondary endpoints11 and was maintained at 36 months for the primary outcome of death/HF hospitalisation (58.8% vs 88%, p<0.001) and secondary endpoints .12 Crossover was permitted to the MitraClip arm at 24 months and this group (53 patients) derived similar benefits to the initial ...

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16 Praz F, Spargias K, Chrissoheris M. et al. Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Lancet 2017; 390: 773-780

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All-cause mortality was lower at 30 days, and we now have 3-year follow-up data confirming persistent mortality benefit (5.9% vs 7.7%), ensuring a guideline recommendation for bivalirudin in primary PCI. 50 The clinical benefits of bivalirudin have also been associated with cost-effectiveness, patient lifetime costs in the UK being £267 lower ... The MitraClip system (Abbott, Abbott Park, IL, USA), which was approved in Europe in 2008 and the USA in 2013, is the first widely available transcatheter therapy for the treatment of both degenerative (primary) and functional (secondary) mitral regurgitation in high-risk and inoperable patients.

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Oct 22, 2020 · LONDON, Oct. 22, 2020 (GLOBE NEWSWIRE) — Information Services Group (Nasdaq: III), a leading global technology research and advisory firm, today announced the Crown Commercial Service (CCS) has awarded ISG a place on the UK Government’s latest G-Cloud framework, G-Cloud 12. A shift to minimal sedation could be possible in a year or two for straightforward MitraClip or PASCAL mitral repairs but will take longer for tricuspid cases because of the complexity.

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After the slam-dunk data on MitraClip presented at TCT in 2018 Abbott is poised to lead the market for mitral valve repair technologies for years to come. Edwards Lifesciences, however, is fighting back, and yesterday added a second string to its bow with European approval of the Pascal system.

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Introduction Despite the challenge of a global pandemic, 2020 has been an invaluable year in cardiology research with numerous important clinical trials published or presented virtually at major international meetings. This article aims to summarise these trials and place them in clinical context. Methods The authors reviewed clinical trials presented at major cardiology conferences during ... The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm ...A. Balloon-Expandable vs. Self-Expanding Valves 4 B. Pre-procedural Planning for TAVR and Valve-In-Surgical Valve 5 C. Implantation Technique for Routine TAVR 5 D. TTE vs. TEE in the Catheterization Laboratory 5 E. Evaluation of Valvular Regurgitation after TAVR 6 1. Aortography 6 2. Hemodynamic Assessment in the Catheterization Laboratory 6 3.

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The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients.Bedeutung für die Praxis: PASCAL ist ein vielversprechendes neues Device zur interventionellen Behandlung der Mitralklappeninsuffizienz. Die Erfolgsrate ist vergleichbar mit dem MitraClip. Weitere Studien werden zeigen, welches Device bei welchen Pathologien zu bevorzugen ist.

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Mar 24, 2020 · Mitral valve regurgitation is a heart defect which leads to a leakage of blood from one ventricle to another. MitraClip and PASCAL are devices which aim to reduce such leakage by clipping the two leaflets of the valve together – “eeTVR” is an acronym for “edge to edge transcatheter valve repair”. The PASCAL device attempts to perform leaflet approximation, as the MitraClip does, but offers more flexibility and maneuverability during deployment. Acknowledging that a real-world experience can differ greatly from a stringently run clinical trial, the editorial writers agree with the need for post-approval data using this novel device.

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Nov 15, 2017 · Thirty-day mortality was significantly lower among patients with procedural success (1.9% vs 6.9%; P = .04). Mean (SD) actuarial survival at 1.5 years was 82.8% (4%) and was significantly higher among patients who had procedural success. Similar results have been reported for individual devices. The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve ... 16 Praz F, Spargias K, Chrissoheris M. et al. Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study. Lancet 2017; 390: 773-780

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Apr 10, 2021 · The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm2, large flail gap (≥ 5 mm) or width (≥ 7 mm ... Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted ...

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Science News features daily news articles, feature stories, reviews and more in all disciplines of science, as well as Science News magazine archives back to 1924. 0 20 40 60 80 100 EVEREST II: 279 pts with 3+/4+ MR randomized 2:1 to MitraClip vs. Surgical Repair Primary Endpoints (per protocol cohort) 0 20 40 60 9.6% Device Group, n=136

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植入装置包括:MitraClip 210例,Trialign 18例,TriCinch一代14例,腔瓣膜植入30例,FORMA 24例,Cardioband 13例,NaviGate 6例,PASCAL 1例。 在64%的病例中,TTVI作为独立手术进行。 3/5Αίθουσα Banquet Hall, MAICC - 18:30-20:00 JOINT SESSION II Πρόεδροι: G. Athanassopoulos,G. Giamouzis,A. Trikas18:30-18:45 Exercise-stress ... MitraClip XTr. The MitraClip XTr was then advanced into the right ventricle just below the leaflet tips. It was slowly opened, exposing the device arms, allowing for exact rotation (Figure 3A). As planned, clipping commenced at the septal-anterior commissure. A second clip was placed just above the first one to increase leaflet coaptation ...

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The primary endpoint was similarly observed in both groups (PASCAL: 91% vs. MitraClip-XTR: 96%). Multiple device implantation was the most common form (59% vs. 82%, p = 0.19), and the occurrence of SLDA was comparable between the PASCAL and MitraClip-XTR system (5.7% [2 of 35 implanted devices] vs. 4.4% [2 of 45 implanted devices], p = 0.99).

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The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients.The ESC heart failure Journal Impact IF 2020-2021 is 3.902. More IF Analysis, Trend, Ranking & Prediction.

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All-cause mortality within 24 months was significantly lower with device-based treatment than with medical therapy alone (29.1% vs. 46.1%; hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001) . The ...

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Diese umfassen unter anderem die Behandlung mit dem MitraClip-System, Pascal-System und dem kathetergestützten Mitral und Trikuspidalklappenersatz. Zur Herzinsuffizienzüberwachung und Therapieoptimierung bieten wir auch im Rahmen von Studien das neue V- LAP System sowie den atrialen Shunt Relieve- HF/ V-Wave an. Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of mitral regurgitation. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clipping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stich.

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Jun 10, 2019 · Over the past 8 years, we have witnessed a significant growth of transcatheter aortic valve replacement (TAVR) replacing 1 of our most commonly performed surgeries, the surgical aortic valve replacement for severe aortic stenosis. In 2017, for the first time, the number of TAVRs performed exceeded surgical aortic valve replacements with or without coronary revascularization.1 Recently, 2 ...

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Jun 28, 2019 · The trial is designed to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL system compared with the Abbott MitraClip device, for the treatment of moderate-to-severe (3+) or severe (4+) functional mitral regurgitation (FMR) in symptomatic heart failure patients. MitraClip is the most widely used device for treatment of severe MR. To overcome some of the shortcomings of MitraClip, novel devices like PASCAL mitral valve repair system are developed. We ...

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JOINT SESSION II Mitral and Tricuspid Club Moderators: G. Athanassopoulos, G. Giamouzis, A. Trikas 1. Exercise-stress echocardiography and effort intolerance... 同时2019年,MitraClip的全球植入量达到的里程碑的10万例,代表着经过近20年的发展,经导管缘对缘技术依然趋于成熟。 此外,缘对缘介入修复器械PASCAL也获得了CE认证,美国FDA临床研究也正在开展,目前临床证据结果也令人振奋。 Target Audience and Goal Statement. This activity is intended for cardiologists and surgeons. The goal of this activity is to educate clinicians who care for patients with valvular heart disease on the current landscape of degenerative mitral valve regurgitation (DMR), including the prevalence and burden of the disease, new and emerging transcatheter leaflet repair interventions to address ...

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Bedeutung für die Praxis: PASCAL ist ein vielversprechendes neues Device zur interventionellen Behandlung der Mitralklappeninsuffizienz. Die Erfolgsrate ist vergleichbar mit dem MitraClip. Weitere Studien werden zeigen, welches Device bei welchen Pathologien zu bevorzugen ist. M.Chrissoheris 16:30-16:45 Transcatheter “Edge-to-Edge” Mitral Valve Repair (MitraClip, PASCAL): Updated patient selection criteria and clinical challenges K.Spargias 16:45-17:00 Patients with severe AS and significant MR. Introduction Despite the challenge of a global pandemic, 2020 has been an invaluable year in cardiology research with numerous important clinical trials published or presented virtually at major international meetings. This article aims to summarise these trials and place them in clinical context. Methods The authors reviewed clinical trials presented at major cardiology conferences during ...

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Jun 25, 2020 · In an accompanying editorial comment, Stephan Windecker, MD, et al., writes that "head-to-head comparisons" of the PASCAL system and MitraClip system "will be of interest." The authors conclude that the "choice between different devices and sizes will further broaden the spectrum of anatomical settings amenable to leaflet approximation enabling ... Variations of the liver standardized uptake value in relation to background blood metabolism: An 2-[18 F]Fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography study in a large population from China

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Mitraclip • Cardioband • TMV replacement ... Edwards PASCAL Mitral Repair System presented by Fabian Praz, The Mitral Valve Meeting, Zurich Feb 2017 ...

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