HeartMate 3 ELEVATE™ Registry
- Conditions
- Cardiovascular DiseaseVentricular DysfunctionHeart Failure
- Interventions
- Device: HeartMate 3
- Registration Number
- NCT02497950
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
- Detailed Description
The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HeartMate 3 HeartMate 3 This registry will include all patients that receive the HM3 LVAS in the post-market setting
- Primary Outcome Measures
Name Time Method Survival Up to 5 Years post-implant Patients will be followed in the registry to 5 years post-implant or outcome (transplanted, explanted for recovery or expired), whichever occurs first.
- Secondary Outcome Measures
Name Time Method EuroQoL-5D-5L (EQ-5D-5L) VAS Baseline, 1, 2, 3, 4, 5 years while the patient is being supported on the HM3 LVAS EuroQoL-5D-5L Visual Analog Score (VAS) measures self-rated health status/quality of life, with the patient indicating his/ger current status of health on a scale from 1 (extremely poor) to 100 (exceptionally good).
Six Minute Walk Test (6MWT) At 5 years after implant The Six Minute Walk Test (6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.
New York Heart Association (NYHA) Classification At 5 years after implant NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort
Adverse Events Up to 5 years post-implant Frequency and incidence of pre-defined anticipated adverse event rates for patients with available data (primary implant and pump exchanges)
Device Malfunctions Up to 5 years post-implant Number of device malfunctions reported
Reoperations Up to 5 years post-implant Frequency and incidence of reoperations after initial implant surgery
Rehospitalizations Up to 5 years post-implant Frequency and incidence of rehospitalizations after initial discharge from implant surgery
Trial Locations
- Locations (26)
Universitätsklinikum Schleswig Holstein
🇩🇪Lubeck, Germany
Sheba Medical Center
🇮🇱Tel Aviv, Israel
Ospedale Civile Maggiore di Verona Borgo Trento
🇮🇹Verona, Italy
UMC Utrecht
🇳🇱Utrecht, Netherlands
Warsaw Institute of Cardiology
🇵🇱Warsaw, Poland
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Institute for Clinical and Experimental Medicine (IKEM)
🇨🇿Prague, Czechia
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Universitatsklinikum Aachen
🇩🇪Aachen, Germany
Universitäts-Herzzentrum Freiburg
🇩🇪Freiberg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Erasmus MC - Thoraxcenter
🇳🇱Rotterdam, Netherlands
Otto-von-Guericke-Universitat Magdeburg
🇩🇪Magdeburg, Germany
National Research Center for Cardiac Surgery
🇰🇿Astana, Kazakhstan
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Rigshospitalet Copenhagen
🇩🇰Copenhagen, Denmark
Herz- und Gefäßklinik Bad Neustadt a d Saale
🇩🇪Bad Neustadt an der Saale, Germany
Herzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Az. Osp. San Camillo Forlanini
🇮🇹Roma, Italy
AJH - Wien
🇦🇹Vienna, Austria
Herz-und Diabetes Zentrum NRW
🇩🇪Bad Oeynhausen, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitätsklinikum Tübingen
🇩🇪Tubingen, Germany
Ospedale San Raffaele
🇮🇹Milano, Italy
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Medizinische Einrichtungen der Universitat Dusseldorf
🇩🇪Dusseldorf, Germany