Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05021601

Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial

Led by China National Center for Cardiovascular Diseases · Updated on 2024-06-13

320

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of bi-atrial ablation versus left atrial ablation during mitral valve surgery in patients with rheumatic mitral valve disease who also have persistent atrial fibrillation. Atrial fibrillation is common in these patients and can increase the risk of death and stroke. The study explores whether targeting both atria provides benefits over treating only the left atrium, especially since right atrial involvement is common in this condition. Participants will undergo mitral valve surgery combined with either a bi-atrial ablation procedure, which treats both the left and right atria, or a left atrial ablation procedure alone. These procedures are performed during open heart surgery and aim to manage atrial fibrillation. The study is randomized and involves two groups receiving one of the two surgical ablation approaches. During the study, participants will be monitored for up to 12 months after surgery. Researchers will assess survival rates without atrial tachyarrhythmia recurrence, both with and without antiarrhythmic drugs, need for permanent pacemaker implantation, burden of atrial fibrillation, major adverse events, and heart function. These evaluations include medical history review, heart rhythm monitoring, and clinical assessments to understand the impact of each ablation method.

CONDITIONS

Brief Title

Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of persistent atrial fibrillation lasting more than 7 days or long-standing persistent atrial fibrillation lasting more than 1 year
  • Rheumatic mitral valve disease requiring mitral valve surgery
  • Consent to surgical ablation of atrial fibrillation
Not Eligible

You will not qualify if you...

  • Paroxysmal atrial fibrillation
  • Degenerative or ischemic mitral valve disease
  • Evidence of active infection
  • Previous catheter or surgical ablation for atrial fibrillation
  • Surgical management of hypertrophic obstructive cardiomyopathy
  • Absolute contraindications for anticoagulation therapy
  • Left atrial thrombosis (except left atrial appendage thrombosis alone)
  • Chronic obstructive pulmonary disease with FEV1 less than 30% predicted
  • Uncontrolled hypo- or hyperthyroidism
  • Mental impairment or conditions preventing understanding of the study
  • Left atrial diameter greater than 70 mm
  • Right ventricular dysfunction or moderate to severe tricuspid regurgitation or pulmonary artery pressure over 60 mmHg
  • Need for coronary artery bypass grafting
  • Previous cardiac surgery
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Duration of hospital stay for surgery and immediate recovery

Participants undergo mitral valve surgery with either bi-atrial ablation or left atrial ablation procedure.

1 surgery visit and several post-operative in-hospital assessments

Post-operative Follow-up

Duration - Up to 12 months after surgery

Participants are monitored for survival, recurrence of atrial tachyarrhythmias, cardiac function, and adverse events after surgery.

Regular follow-up visits over 12 months

Trial Site Locations

Total: 2 locations

1

Fuwai Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

Z

Zhe Zheng, MD,PhD

C

Chunyu Yu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial.

Chunyu Yu, Haojie Li, Yang Wang...

https://pubmed.ncbi.nlm.nih.gov/36446460