Clinical Trial

Corheart 6: Long-term Cohort Study

Recruiting
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Summary
This study aims to evaluate the long-term effectiveness and safety of Corheart 6 left ventricular assist system as a treatment for patients with advanced left heart failure. The patients who have received the Corheart 6 treatment since October 2021, or who are planned to received it, will be enrolled until the target sample size meets statistical requirements. Data collected will include survival status, cardiac function status, quality of life, laboratory parameters and adverse events. The primary endpoint are the composite of survival at 6 months and, separately, at 24 months, defined as survival with device support, bridge to heart transplant and device explantation due to cardiac recovery, without disabling stroke (mRS \> 3) or device replacement. Data collection will adhere to the follow-up schedule specified in the protocol.
Trial Details
NCT Number NCT07094919
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions Heart Failure
Enrollment 160 participants
Start Date 2021-12-12
Primary Completion 2027-09-30 (estimated)
Study Completion 2030-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-31