Personalized CRT - MPP Post Approval Study
2021年2月15日 更新者：Medtronic
Personalized CRT - Multiple Point Pacing Post Approval Study
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release.
This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy.
Patients will be followed for the duration of the PAS.
This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
研究概览
详细说明
Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities receiving appropriate license or regulatory approval during the conduct of the PAS were included and contributed to the PAS objectives upon commercial release. CRT is an established pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized biventricular (BiV) pacing using standard pacing technology combined with a special third lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced event, both ventricles are stimulated to synchronize their contraction. The MPP feature is designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either before or after the LV paces, with the order determined by the programmed Ventricular Pacing Configuration.
The MPP PAS was a global, prospective, observational multi-center study. Patients implanted with an eligible CRT Quad system were enrolled and followed in the Product Surveillance Registry per the expected standard of care practices of their care provider.
研究类型
观察性的
注册 (实际的)
1338
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Montreal、Quebec、加拿大、H1T 1C8
- Montreal Heart Institute
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Québec、Quebec、加拿大、G1V 4G5
- Institut de cardiologie et de pneumologie de Québec (IUCPQ)
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Budapest、匈牙利、1134
- Magyar Honvédség Honvédkorház
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Seoul、大韩民国、135-710
- Samsung Medical Center
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Aachen、德国、52074
- Universitätsklinikum Aachen, AöR
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Essen、德国、045147
- Universitatsklinikum Essen
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Homburg、德国、66421
- Universitätsklinikum des Saarlandes
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Köln、德国、50733
- St. Vinzenz-Hospital Köln
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Tübingen、德国、72076
- Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
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Ulm、德国、89081
- Universitatsklinikum Ulm
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Milano、意大利、20162
- Azienda Ospedaliera Ospedale Niguarda Ca Granda
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Kosice、斯洛伐克、04011
- Východoslovenský Ústav Srdcových A Cievnych Chorôb, A.S.
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Leuven、比利时、3000
- UZ Leuven - Campus Gasthuisberg
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Yvoir、比利时、5530
- CHU UCL Mont-Godinne - Dinant
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Brest、法国、29609
- CHRU Brest - Hôpital de la Cavale Blanche
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Clermont-Ferrand、法国、63003
- Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
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La Rochelle、法国、17019
- CHRU La Rochelle
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Montpellier、法国、34295
- CHU de Montpellier - Hôpital Arnaud de Villeneuve
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Nantes、法国、44277
- Nouvelles Cliniques Nantaises
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Pringy、法国、74374
- Centre hospitalier de la région d'Annecy
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Alabama
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Birmingham、Alabama、美国、35294-0001
- University of Alabama at Birmingham
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Arkansas
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Little Rock、Arkansas、美国、72205-6202
- Saint Vincent Heart Clinic Arkansas
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California
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Chula Vista、California、美国、91910
- Chula Vista Cardiac Center
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Palm Springs、California、美国、92262
- Desert Heart Rhythm Consultants
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Torrance、California、美国、90505
- COR Healthcare
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Colorado
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Colorado Springs、Colorado、美国、80907
- Colorado Springs Cardiology
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Denver、Colorado、美国、80204
- Denver Heart
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Lakewood、Colorado、美国、80228
- Colorado Heart and Vascular, PC
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Florida
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Hollywood、Florida、美国、33021
- Heart Rhythm Solutions
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Jacksonville、Florida、美国、32207
- Baptist Health
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Safety Harbor、Florida、美国、34695-6604
- Heart & Vascular Institute of Florida
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Georgia
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Albany、Georgia、美国、31701
- Phoebe Putney Memorial Hospital
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Kansas
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Kansas City、Kansas、美国、66160-8500
- The University of Kansas Medical Center
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Maryland
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Baltimore、Maryland、美国、21237-3958
- MedStar Health Research Institute
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Bethesda、Maryland、美国、20817
- The Johns Hopkins Hospital
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Salisbury、Maryland、美国、21804-6938
- Delmarva Heart Research Foundation Inc
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Boston、Massachusetts、美国、02114-2621
- Massachusetts General Hospital
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Michigan
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Marquette、Michigan、美国、49855-2705
- UP Health System - Marquette
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Ypsilanti、Michigan、美国、48197-8633
- Michigan Heart
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Minnesota
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Minneapolis、Minnesota、美国、55407-1157
- Minneapolis Heart Institute Foundation
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Robbinsdale、Minnesota、美国、55422
- North Memorial Heart and Vascular Institute
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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Missouri
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Columbia、Missouri、美国、65201-8023
- Missouri Cardiovascular Specialists
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Saint Louis、Missouri、美国、63110-1010
- Washington University School of Medicine
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Nevada
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Henderson、Nevada、美国、89052-4171
- HealthCare Partners Medical Group
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New Mexico
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Albuquerque、New Mexico、美国、87106-4921
- Presbyterian Heart Group
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New York
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Garden City、New York、美国、11530-1613
- Island Cardiac Specialists
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Huntington、New York、美国、11743-2787
- Huntington Hospital
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Manhasset、New York、美国、11030
- Northwell Health
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Poughkeepsie、New York、美国、12601-3923
- Hudson Valley Heart Center
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Utica、New York、美国、13501-5930
- Central New York Cardiology
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North Carolina
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Raleigh、North Carolina、美国、27610
- WakeMed Health & Hospitals
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Ohio
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Akron、Ohio、美国、44304-1473
- Northeast Ohio Cardiovascular Specialists
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Cincinnati、Ohio、美国、45267-0542
- University of Cincinnati
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Cincinnati、Ohio、美国、45219
- The Christ Hospital Health Network
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Toledo、Ohio、美国、43608
- Mercy Health - Saint Vincent Medical Center
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Oklahoma
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Cleveland、Oklahoma、美国、44195-0001
- Cleveland Clinic
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Pennsylvania
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Allentown、Pennsylvania、美国、18103-6381
- Lehigh Valley Health Network
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Danville、Pennsylvania、美国、17822
- Geisinger Medical Center
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Wilkes-Barre、Pennsylvania、美国、18711
- Geisinger Wyoming Valley Medical Center
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Tennessee
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Nashville、Tennessee、美国、37205-2018
- Saint Thomas Research Institute
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Texas
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Austin、Texas、美国、78705-1852
- Texas Cardiac Arrhythmia Research Foundation
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Vermont
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Burlington、Vermont、美国、05401
- The University of Vermont Medical Center
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Washington
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Spokane、Washington、美国、99204-2352
- Kootenai Heart Clinics Northwest
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Wisconsin
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Milwaukee、Wisconsin、美国、53215
- Aurora Cardiovascular Services
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Birmingham、英国、B15 2GW
- University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
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Leicester、英国、LE3 9QP
- Glenfield Hospital
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Liverpool、英国、L14 3PE
- Liverpool Heart and Chest Hospital NHS Foundation Trust
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Manchester、英国、M13 9WL
- Central Manchester University Hospitals NHS - Manchester Royal Infirmary
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Middlesbrough、英国、TS4 3BW
- The James Cook University Hospital - South Tees Hospitals NHS
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Maastricht、荷兰、6229 HX
- Maastricht Universitair Medisch Centrum
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Rotterdam、荷兰、3079 DZ
- Maasstad Hospital Rotterdam
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A Coruña、西班牙、15006
- Hospital Universitario da Coruna
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Madrid、西班牙、28007
- Hospital General Universitario Gregorio Marañon
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Palma de Mallorca、西班牙、07210
- Hospital Universitario Son Espases
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Santiago de Compostela、西班牙、15706
- Complejo Hospitalario Universitario de Santiago de Compostela
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Kuala Lumpur、马来西亚、50400
- Institut Jantung Negara - National Heart Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The study population includes patients that are or will be implanted with an eligible CRT Quad system.
描述
Inclusion Criteria:
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with an eligible CRT device
- Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Exclusion Criteria:
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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CRT non-responders with MPP enabled
Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.
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The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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MPP therapy responder
大体时间：Up to 3 years
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To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
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Up to 3 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HF hospitalization and/or mortality
大体时间：Up to 3 years
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Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled
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Up to 3 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月5日
初级完成 (实际的)
2020年6月4日
研究完成 (实际的)
2021年1月7日
研究注册日期
首次提交
2017年7月26日
首先提交符合 QC 标准的
2017年7月26日
首次发布 (实际的)
2017年7月28日
研究记录更新
最后更新发布 (实际的)
2021年2月17日
上次提交的符合 QC 标准的更新
2021年2月15日
最后验证
2021年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.