Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

NCT05883722 | Unknown

• 1 other identifier: KS(Y)23218
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Conditions

Atrial Fibrillation, Persistent

Keywords

catheter ablation; atrial fibrillation; Driver ablation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation recurrence

  any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure.

  12 months

Secondary Outcomes (1)

• Atrial fibrillation/atrial tachycardia recurrence

  12 months

Study Arms (2)

RA group

EXPERIMENTAL

The RA group received adjunctive right atrial ablation in addition to left side ablation.

Procedure: Catheter ablation

Control group

ACTIVE COMPARATOR

The control group received left side ablation only.

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation

Control group; RA group

Eligibility Criteria

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

You may qualify if:

• Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;
• Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

You may not qualify if:

• Uncontrolled congestive heart failure;
• History of severe valve disease and/or prosthetic valve replacement;
• Myocardial infarction or stroke within 6 months;
• Severe congenital heart disease;
• EF \<40%;
• Contrast agent allergy;
• The use of anticoagulant drugs is contraindicated;
• Severe lung disease;
• Left atrial thrombus confirmed by preoperative esophageal ultrasound;
• Contraindications for cardiac catheterization;
• Atrial fibrillation ablation;
• Have performed any cardiac surgery within 2 months;
• Poor general health;
• Life expectancy \< 6 months.

Sponsors & Collaborators

• Xu Liu: lead
• The Third Xiangya Hospital of Central South University: collaborator
• Yangpu District Central Hospital Affiliated to Tongji University: 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 1, 2023
• Study Start: June 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 1, 2023

Record last verified: 2023-05