N/A
N=101
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01832610 ↗Enrolled (actual)
101
Serious AEs
73.8%
Results posted
Jul 2019
Primary outcome: Primary: Overall Survival on Device — 52.9 Percent Probability of Survival
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- HeartWare® VAS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival on Device |
52.9 | — |
| SECONDARY Final Patient Status |
21; 5; 41; 0; 22; 6 | — |
| SECONDARY Re-hospitalizations |
3.9 | — |
| SECONDARY Number of Participants Experiencing Any Adverse Event Per Intermacs Definition |
66 | — |
| SECONDARY Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) |
20.1 | — |
| SECONDARY Health Status Change Measured by EuroQol EQ-5D (Version 5L) |
66.84 | — |
| SECONDARY Change in Functional Status Measured by New York Heart Association (NYHA) Class |
2; 5; 7; 8 | — |
| SECONDARY Change in Functional Status Measured by 6-minute Walk |
106.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
Data sourced from ClinicalTrials.gov (NCT01832610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.