Termination of Persistent Atrial Fibrillation by Catheter Ablation

July 9, 2021 updated by: Xu Liu, Shanghai Chest Hospital

A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation

This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

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

Study Contact

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with persistent AF.

Description

Inclusion Criteria:

1. Aged 18 to 80 years old; 2. Persistent AF; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion Criteria:

  1. With uncontrolled congestive heart failure;
  2. Having significant valvular disease and/or prosthetic heart valve(s);
  3. With myocardial infarction or stroke within 6 months of screening;
  4. With Significant congenital heart disease;
  5. Ejection fraction was <40% measured by echocardiography;
  6. Allergic to contrast media;
  7. Contraindication to anticoagulation medications;
  8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
  9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
  10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

12. Presence of an implanted cardioverter-defibrillator; 13. Any cardiac surgery within the past 2 months; 14. Poor general health; 15.Life expectancy less than 6 months.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Persistent AF Group
All patients received radiofrequncy ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF recurrence rate
Time Frame: 12 months
AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
12 months

Collaborators and Investigators

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

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 (ANTICIPATED)

August 1, 2021

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 9, 2021

First Posted (ACTUAL)

July 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Termination-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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