Skip to main content
OpenTrials
Completed

NCT Number: NCT03836092

ECGI in Patients With Persistent Atrial Fibrillation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bumrungrad International Hospital

Bangkok, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation

Procedure

RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).

Primary outcomes

  1. Freedom from Atrial Fibrillation

    Time frame: 1 year

    termination via ablation from atrial fibrillation during follow up period

Secondary outcomes

  1. termination via ablation from atrial fibrillation during procedure

    Time frame: over 6 months

    Termination of AF to NSR during procedure

Sponsors and collaborators

Lead sponsor

Pacific Rim Electrophysiology Research Institute

Other

Registry information

Official study title

Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2019
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.