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

NCT06703528 | Not Yet Recruiting DMC

• 1 other identifier: 2024-2413
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

atrial fibrillation; heart valve diseases

Outcome Measures

Primary Outcomes (2)

• Perioperative and 6-month postoperative cardiac and cerebrovascular-related adverse event rates

  Cardiac and cerebrovascular-related adverse events included all-cause mortality, stroke, systematic embolism, repeat cardiac surgery, heart failure requiring hospitalization, ablation-related coronary artery stenosis/occlusion, pulmonary vein stenosis, and permanent pacemaker implantation rates.

  From enrollment to the end of the trial at 6 months

• The probability of freedom from atrial tachyarrhythmias at 6 months after cryoablation

  The probability of freedom from atrial fibrillation, atrial flutter, and atrial tachycardia in the absence of class I/III antiarrhythmic drugs at 6 months postoperatively.

  From enrollment to the end of the trial at 6 months

Interventions

cryoablation DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are aged between 18-75 years old, with heart valve disease requiring surgery and combined with atrial fibrillation, no previous cardiac surgery, no myocardial infarction or stroke within 3 months, no absolute contraindications to anticoagulation, no other cardiac disease that does not require surgical treatment, no diagnosis of coronary artery disease, no active infections, no serious insufficiency of the liver, kidneys, cardiopulmonary function, no thrombus in the cardiac cavity, and the internal diameter of left atrium is no more than 70mm and the left ventricular ejection fraction is not less than 50%.

You may qualify if:

• patients with valvular disease (e.g., mitral, tricuspid, and aortic valve disease) requiring surgical intervention;
• patients with atrial fibrillation who consent to cryoablation;
• years of age (as of the date of signing the informed consent form);
• signing the patient's informed consent.

You may not qualify if:

• intracardiac thrombosis;
• patients with absolute contraindications to anticoagulation;
• combination of other cardiac diseases requiring surgical treatment;
• patients with a diagnosis of coronary artery disease (coronary artery enhancement CT or coronary angiography suggesting that any one of the three coronary vessels and their major branches has a stenosis greater than or equal to 50%);
• patients with generalized malignant disease or severe insufficiency of liver, kidney, heart and lung functions;
• patients with current active infection;
• pregnant and lactating patients;
• patients with a prior history of cardiac surgery;
• patients with myocardial infarction within the last 3 months;
• patients who have suffered a stroke within the last 3 months;
• patients with an anterior-posterior left atrial diameter greater than 70 mm;
• left ventricular ejection fraction (LVEF) \<50%;
• patients who are not expected to complete the 6-month postoperative follow-up;
• those who are participating in other clinical trials and have not met the primary endpoint;
• those who, in the opinion of the investigator, are not suitable for participation in this clinical study.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Zhe Zheng, MD,PhD

CONTACT

+86 10 8839 8265; zhengzhe@fuwai.com

Chunyu Yu, MD, PhD

CONTACT

yuchunyu@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 25, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share