Termination of Persistent Atrial Fibrillation by Catheter Ablation

NCT04958928 | Unknown

• 1 other identifier: Termination-AF
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• AF recurrence rate

  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

Study Arms (1)

Persistent AF Group

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

All patients received radiofrequncy ablation.

Persistent AF Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with persistent AF.

You may qualify if:

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

You may not qualify if:

• 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;
• \. 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Wuhan Central Hospital: collaborator
• Ruijin Hospital: collaborator
• Beijing Chao Yang Hospital: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• The Third People's Hospital of Chengdu: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Qin Mu, MD

CONTACT

+8613052320103; qinmuae@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share