Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05021601

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

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

320

Participants Needed

2

Research Sites

164 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.

CONDITIONS

Official 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 or long-standing persistent atrial fibrillation confirmed by medical history and Holter monitoring
  • Rheumatic mitral valve disease requiring mitral valve surgery confirmed by history, valve morphology, echocardiography, and pathological diagnosis
  • Agreement to undergo 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 treatment for hypertrophic obstructive cardiomyopathy
  • Absolute contraindications to anticoagulation therapy
  • Left atrial thrombosis (except left atrial appendage thrombosis alone)
  • Severe chronic obstructive pulmonary disease (FEV1 <30% predicted)
  • Uncontrolled hypo- or hyperthyroidism
  • Mental impairment or other conditions preventing understanding of the study
  • Left atrial diameter greater than 70 mm
  • Right ventricular dysfunction (TAPSE <16), moderate to severe tricuspid regurgitation, or pulmonary artery pressure over 60 mmHg
  • Need for coronary artery bypass grafting due to coronary heart disease
  • 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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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

CONTACT

C

Chunyu Yu, MD

CONTACT

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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