- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958928
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
- Name: Qin Mu, MD
- Phone Number: +8613052320103
- Email: qinmuae@163.com
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:
- With uncontrolled congestive heart failure;
- Having significant valvular disease and/or prosthetic heart valve(s);
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
- 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.
Sponsor
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
Additional Relevant MeSH Terms
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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Clinical Trials on Catheter ablation
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