Outcomes of a Novel Magnetically Levitated LVAD: a Multicenter Analysis

NCT06596499 | Completed

• 1 other identifier: KS2024086
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Keywords

Heart Failure; Left ventricular assist device; CH-VAD; Outcomes

Outcome Measures

Primary Outcomes (2)

• short-term primary outcome

  The short-term primary outcome is a composite of survival to transplant, myocardial recovery, reoperation to replace the original pump or heart transplantation within 30 days or during hospitalization.

  30 days

• long-term primary outcome

  The long-term primary outcome is a composite of survival to transplant, myocardial recovery, reoperation to replace the original pump or heart transplantation at 1 year postoperatively.

  1 year

Study Arms (1)

CH-VAD

All patients implanted with the CH-VAD as the primary device

Device: CH-VAD

Interventions

CH-VAD DEVICE

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

CH-VAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All decisions to undergo surgery came from the multidisciplinary heart failure team including cardiac surgeons, cardiologists, echocardiography specialists, cardiovascular anaesthesiologists, nurses and other specialists. All patients implanted with the CH-VAD as the primary device in a post-market approval setting were included.

You may qualify if:

• All patients implanted with the CH-VAD as the primary device in a post-market approval setting were included.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Shanghai Chest Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Wuhan Asia Heart Hospital: collaborator
• Henan Provincial Chest Hospital: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Jiangsu Provincial People's Hospital: collaborator

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)