Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
HW-PAS-03
A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
1 other identifier
observational
101
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
July 11, 2019
CompletedJuly 11, 2019
April 1, 2019
4.8 years
April 10, 2013
December 19, 2018
April 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival on Device
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.
Implant to 5 years
Secondary Outcomes (7)
Final Patient Status
Implant to 5 years
Re-hospitalizations
Enrollment into HW-PAS-03 to 5 years
Number of Participants Experiencing Any Adverse Event Per Intermacs Definition
Enrollment into HW-PAS-03 to 5 years
Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change from baseline to 5 years
Health Status Change Measured by EuroQol EQ-5D (Version 5L)
Enrollment to 5 years
- +2 more secondary outcomes
Study Arms (1)
HeartWare® VAS
Ventricular Assist Device (HeartWare® VAS)
Interventions
The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
Eligibility Criteria
The patient population consists of patients who were at risk of death from refractory, advanced heart failure and implanted with a HeartWare® Ventricular Assist System under IDE G070199. Patients must have participated as a study patient in a prior HeartWare trial under IDE G070199, and been implanted with the HeartWare® System
You may qualify if:
- 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.
You may not qualify if:
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Stanford University School of Medicine
Stanford, California, 94305, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida - Gainesville
Gainesville, Florida, 32610, United States
University of Miami / Jackson Memorial Hospital
Miami, Florida, 33136, United States
The Emory Clinic Inc.
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
IU Health Methodist
Indianapolis, Indiana, 46202, United States
Jewish Hospital - Rudd Heart and Lung Institute
Louisville, Kentucky, 40202, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
University of Texas - South Western
Dallas, Texas, 75390, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Northwest Cardiothoracic &Transplant Surgeons
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Vassiliades, MD - VP MCS Clinical/Medical Affairs
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 16, 2013
Study Start
January 1, 2013
Primary Completion
November 1, 2017
Study Completion
March 1, 2018
Last Updated
July 11, 2019
Results First Posted
July 11, 2019
Record last verified: 2019-04