Outcomes of a Novel Magnetically Levitated LVAD: a Multicenter Analysis

Brief summary (registry, in English)

This multicenter, retrospective cohort study evaluates the clinical outcomes associated with a novel fully magnetically levitated left ventricular assist device (LVAD) in patients with advanced heart failure. Data were collected from seven medical centers in China, involving patients who received the CH-VAD device between June 1, 2022, and June 30, 2024. The study aims to assess short-term and long-term outcomes, including survival, myocardial recovery, and device-related complications. The CH-VAD is designed with a magnetically levitated rotor to minimize mechanical wear and the risk of thrombosis. Patients included in the study were those with end-stage heart failure, selected based on specific clinical criteria, with the CH-VAD being the primary mechanical circulatory support device. Data were extracted from electronic medical records, including demographic information, clinical characteristics, surgical details, and postoperative outcomes. Exposure factors analyzed include patient demographics, preoperative conditions, and details of the CH-VAD implantation. The primary endpoints were survival to transplant, myocardial recovery, reoperation to replace the original pump, or heart transplantation within 30 days and at 1 year postoperatively. Secondary outcomes included adverse events such as device thrombosis, stroke, and major bleeding. Statistical analysis was conducted using Kaplan-Meier survival curves and multivariable regression models to evaluate outcomes. The study was approved by the Institutional Ethics Committee of Anzhen Hospital, with a waiver of informed consent due to its retrospective nature. This study provides data on the clinical outcomes associated with the CH-VAD, contributing to the understanding of its use in patients with end-stage heart failure.

What you commit to

• Study type: Observational
• Participants enrolled: 75
• From 1 Jun 2022 to the primary completion date, 1 Aug 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.