ECGI in Patients With Persistent Atrial Fibrillation

April 9, 2022 updated by: Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute

Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Bumrungrad International Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Atrial Fibrillation
Time Frame: 1 year
termination via ablation from atrial fibrillation during follow up period
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
termination via ablation from atrial fibrillation during procedure
Time Frame: over 6 months
Termination of AF to NSR during procedure
over 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Rim Electrophysiology Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 23, 2018

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (ACTUAL)

February 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACIFICRERI3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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