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Outcomes of a Novel Magnetically Levitated LVAD: a Multicenter Analysis

NCT06596499 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-09-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

CH-VAD

The CH-VAD pump is a fully magnetically levitated (maglev), centrifugal continuous-flow blood pump.

Sponsors & Collaborators

  • Shanghai Chest Hospital

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Wuhan Asia Heart Hospital

    collaborator OTHER

  • Henan Provincial Chest Hospital

    collaborator OTHER

  • Sichuan Provincial People's Hospital

    collaborator UNKNOWN

  • Jiangsu Provincial People's Hospital

    collaborator UNKNOWN

  • Beijing Anzhen Hospital

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06596499 on ClinicalTrials.gov