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An Exploratory Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Surgical Cryoablation System for the Treatment of Atrial Fibrillation

NCT06703528 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-11-25

No results posted yet for this study

Summary

The goal of this prospective, observational study is to evaluate the safety and efficacy of a cardiac surgical cryoablation system for the treatment of atrial fibrillation. This study will be conducted at Fuwai Hospital in China. A total of 10 subjects with heart valve diseases (e.g., mitral, tricuspid, and aortic valve diseases) requiring surgical treatment and with atrial fibrillation will be enrolled in the study, and all of them will undergo surgical ablation using surgical cryoablation devices (cryoablation clamps and pens) with follow-up visits at 3 and 6 months after the procedure. In this study, the incidence of cardiac and cerebrovascular-related adverse events in the perioperative period and at 6 months after procedure is defined as the primary safety endpoint (all-cause mortality, stroke, systematic embolism, cardiac reoperations, heart failure requiring hospitalization, ablation-related coronary artery stenosis/occlusion, pulmonary vein stenosis, and rate of permanent pacemaker implantation.). The primary efficacy endpoint is the probability of freedom from atrial tachyarrhythmias at 6 months after the procedure. Device ease of use, technical success, ablation procedure time, and assessment of the incidence of device defects are defined as secondary endpoints.

Conditions

  • Atrial Fibrillation (AF)
  • Heart Valve Diseases

Interventions

DEVICE

cryoablation

The therapeutic cryoablation agent used in this trial was liquid nitrogen with an evaporation temperature of -196°C, which was transported to the ablation pen through a vacuum line to exchange energy at the heart site to perform cryoablation.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-06-30
Completion
2026-08-31

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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 NCT06703528 on ClinicalTrials.gov