Cyroablation for Pulmonary Vein Isolation Alone in Patients with Early Persistent AF Assessed by Continuous Monitoring

NCT05507749 | Active Not Recruiting DMC

• 1 other identifier: COOL PER
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy of Cryoablation in patients with early persistent atrial fibrillation as a first index procedure using continuous cardiac rhythm monitoring.

Conditions

Atrial Fibrillation, Persistent

Keywords

Cryoablation

Outcome Measures

Primary Outcomes (1)

• Change of implantable cardiac monitor-detected atrial fibrillation/atrial flutter burden.

  The percentage of time spent in atrial fibrillation (hours of atrial fibrillation/hours of monitoring) during the first year after pulmonary vein isolation (excluding a 3-month window) compared to pre-ablation atrial fibrillation/atrial flutter burden.

  After cryoablation (between 3-month and 1-year) and pre-ablation

Secondary Outcomes (5)

• Time to the first recurrence of atrial fibrillation/atrial flutter

  From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.

• Recurrence nature of atrial fibrillation

  From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.

• 36-Item Short Form Health Survey composite scores

  Pre-ablation and 1-year after ablation

• European Heart Rhythm Association score

  Pre-ablation and 1-year after ablation

• Atrial fibrillation/atrial flutter recurrence and changes in atrial fibrillation/atrial flutter burden

  From 3-month after cryoablation to the removal of the implantable loop recorder, up to 3years.

Study Arms (1)

a group of participants receive implantable loop recorder before cryoballoon ablation

EXPERIMENTAL

Following enrollment, an implantable loop recorder is implanted in all participants for the purpose of arrhythmia (any atrial fibrillation or atrial tachycardia) detection (Reveal LINQ, Medtronic, Minneapolis, MN).

Procedure: cryoballoon ablation; Device: implantable loop recorder insertion

Interventions

cryoballoon ablation PROCEDURE

Cryoballoon ablation for the treatment of atrial fibrillation

a group of participants receive implantable loop recorder before cryoballoon ablation

implantable loop recorder insertion DEVICE

The device called a implantable loop recorder, is placed just under the skin of one's chest during a minor surgery.

a group of participants receive implantable loop recorder before cryoballoon ablation

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug refractory symptomatic persistent atrial fibrillation diagnosed within 3 years
• Either two conditions
• atrial fibrillation episode lasting longer than 7 days, but less than 3 years documented by consecutive electrocardiogram recordings of 100% atrial fibrillation greater than 7 days apart or
• atrial fibrillation episode requiring electrical or pharmacological cardioversion after 24 hours of atrial fibrillation documented by continuous recording
• Willing to comply with study requirements and give informed consent to participate in this clinical study

You may not qualify if:

• Long-standing persistent atrial fibrillation more than 3 years
• Sinus rhythm at enrollment
• Recurrent sinus rhythm after electrical cardioversion
• Severe left ventricular dysfuncion (left ventricle ejection fraction \< 30%)
• Previous ablation procedure or surgery for atrial fibrillation
• Contraindication to chronic anticoagulation therapy or heparin
• Documented left atrial diameter \>50 mm from parasternal long-axis view
• A percutaneous coronary intervention or myocardial infarction ≤3 months
• A stroke or transient ischemic attack ≤6 months
• Planned cardiovascular intervention
• Mental or physical inability to participate in the study
• Participation in another randomized clinical trial
• Uncontrolled hypertension, untreated hypothyroidism or hyperthyroidism
• Requirement for dialysis due to terminal renal failure

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Hallym University Medical Center: collaborator
• Asan Medical Center: collaborator

Study Sites (1)

Seoul National university Hostpital

Seoul, Jongno-gu, 03080, South Korea

Location

Related Publications (1)

• Lee SR, Choi EK, Lee KY, Choi J, Ahn HJ, Kwon S, On YK, Lee JH, Cho Y, Oh IY, Lim HE, Cho MS, Nam GB, Lip GYH, Oh S. Reduction of AF Burden After Cryoballoon Ablation in Patients With Early Persistent AF: The COOL-PER Trial. JACC Clin Electrophysiol. 2025 Jun;11(6):1234-1247. doi: 10.1016/j.jacep.2025.02.006. Epub 2025 Mar 26.

  PMID: 40146092 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Eue-Keun Choi, M.D. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 19, 2022
• Study Start: November 27, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)