ECGI in Patients With Persistent Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03836092
• Lead Sponsor: Pacific Rim Electrophysiology Research Institute

Brief Summary

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.

Detailed Description

The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine:

* The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF.

* The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE).

* If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system.

* The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI

Study Timeline

• Study Start: 2018-02-23
• Study First Submitted: 2019-01-27
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Primary Completion: 2022-01-01
• Status Verified: 2022-04
• Study Completion: 2022-04-01
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months.
• Patients who are symptomatic
• Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic

Exclusion Criteria

• Patients under 18 years or over 85 years of age.
• Patients with chronic alcoholism.
• Recent myocardial infarction within one month of the study.
• Significant debilitating diseases or a terminal disease.
• Patients with documented left atrial thrombus.
• Medical or mental conditions precluding a long-term follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from Atrial Fibrillation	1 year	termination via ablation from atrial fibrillation during follow up period

Secondary Outcome Measures

Name	Time	Method
termination via ablation from atrial fibrillation during procedure	over 6 months	Termination of AF to NSR during procedure

Trial Locations

Locations (1)

Bumrungrad International Hospital; 🇹🇭 Bangkok, Thailand