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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060040 S005/ PAS001 |
| Date Original Protocol Accepted |
05/07/2010
|
| Date Current Protocol Accepted |
05/07/2010
|
| Study Name |
Destination Therapy-INTERMACS
|
| Device Name |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective registry of patients receiving the HeartMate II LVAS for the Destination Therapy indication. The purpose of a post-approval study for the HeartMate II as Destination Therapy is to assess whether the commercial use of the device produces results that are comparable to results observed in the HM II Destination Therapy clinical trial.
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| Study Population |
Study Populaton: The post-approval study is a prospective registry of patients receiving the HeartMate II LVAS for the Destination Therapy indication. The HeartMate II LVAS is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate II LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class 3B or 4 with endstage left ventricular failure who have received therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation.
|
| Sample Size |
247 patients, over 105 sites, utilizing the INTERMACS Registry
|
| Key Study Endpoints |
The primary objective of the HeartMate II Destination Therapy Post-Approval Study is to assess two-year patient survival free of stroke or reoperation to replace the device following HeartMate II implantation for Destination Therapyin a commercial setting. The following secondary objectives will be evaluated: 1) Incidence of adverse events 2) Clinical reliability; percutaneous lead (malfunctions/failures), and 3) Quality of Life as measured by EuroQOL instrument.
|
| Follow-up Visits and Length of Follow-up |
Post implant, patients will be assessed at 1 week, 1, 3, 6, 12, and 24 months.
|
| Interim or Final Data Summary |
| Interim Results |
No safety data is available for this study.
|
| Actual Number of Patients Enrolled |
247
|
| Actual Number of Sites Enrolled |
61
|
| Patient Follow-up Rate |
99.6%
|
| Final Safety Findings |
Most frequent overall:
Bleeding (54%, 0.84 per patient year [ppy]) Infection (57%, 0.88 ppy)
Respiratory failure (27%, 0.23 ppy)
Most frequent <30 Days: Bleeding (38%, 7.19 ppy) Infection (24%, 4.23 ppy)
Respiratory failure (19%, 3.01 ppy)
Most frequent >30 Days Bleeding (36%, 0.50 ppy) Infection (52%, 0.70 ppy)
Cardiac Arrhythmia (24%, 0.23 ppy) Device Malfunction (17%, 0.13 ppy)
There were 9 reports of thrombus as reported by INTERMACS.
- Death n=1
- Exchange/explant n=9
- Support durations 0.2 - 16.9 months
QoL improved for both patient groups from pre-implant to 24 months.
|
| Final Effect Findings |
Success rate including transplant/recovery pts HMI II ¿ 139 (56%) vs. IDE ¿ 58 (44%); p=0.0236
Success rate excluding transplant/recover pts
HMI II ¿ 54% vs. IDE 44%; p=0.0819
24-month survival for HM II ¿ 61.3%
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| Study Strengths & Weaknesses |
High follow-up rate, but concerns about possible unreported adverse events. Without a requirement for device explant studies, no further investigation into the location of the 9 thrombus events can be conducted.
|
| Recommendations for Labeling Changes |
yes
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