Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
- Conditions
- Heart Failure
- Interventions
- Device: HeartWare® VAS
- Registration Number
- NCT01832610
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
- Detailed Description
Patients who participated in prior trials will be approached for this PAS as follows:
* Patients who are on continued HeartWare® System support, (original or exchange device)
* Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- The patient has participated in a prior HeartWare trial under IDE G070199.
- The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
- The patient has signed informed consent for participation in the study.
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HeartWare® VAS HeartWare® VAS Ventricular Assist Device (HeartWare® VAS)
- Primary Outcome Measures
Name Time Method Overall Survival on Device Implant to 5 years Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
- Secondary Outcome Measures
Name Time Method Change in Functional Status Measured by 6-minute Walk Change from baseline to 5 years Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.
Final Patient Status Implant to 5 years The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition Enrollment into HW-PAS-03 to 5 years Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.
Health Status Change Measured by EuroQol EQ-5D (Version 5L) Enrollment to 5 years The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).
Re-hospitalizations Enrollment into HW-PAS-03 to 5 years A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Change from baseline to 5 years Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.
Change in Functional Status Measured by New York Heart Association (NYHA) Class Change from baseline to 5 years Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:
I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.
II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III).
Trial Locations
- Locations (25)
Stanford University School of Medicine
🇺🇸Stanford, California, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
The Emory Clinic Inc.
🇺🇸Atlanta, Georgia, United States
University of Miami / Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
IU Health Methodist
🇺🇸Indianapolis, Indiana, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Jewish Hospital - Rudd Heart and Lung Institute
🇺🇸Louisville, Kentucky, United States
Washington University / Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas - South Western
🇺🇸Dallas, Texas, United States
Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwest Cardiothoracic &Transplant Surgeons
🇺🇸Spokane, Washington, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States