Status:
COMPLETED
Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Wannan Medical College
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
65-80 years
Phase:
NA
Brief Summary
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in older patients with paroxysmal AF: Pulmonary vein isolation alone versus additional lo...
Detailed Description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder. Catheter ablation to the pulmonary veins isolation (PVI) electrically from the left atrium (LA) has been shown to be an...
Eligibility Criteria
Inclusion
- Patients age is 65-80 years;
- Patients with paroxysmal AF;
- Patients can sign the written informed consent for the study;
- Patients can endure the required follow-up.
Exclusion
- Patients with previous radiofrequency ablation;
- Patients with PLT count less than 80×109/L, or with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor;
- Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view);
- Patients with thromboemboli in LA (TEE or MSCT);
- Patients with severe structural cardiac disease (medium or severe mitral regurgitation, DCM, HCM, or other severe valvular heart diseases);
- Patients with abnormal thyroid function;
- Patients with severe liver or renal dysfunction (AST or ALT \> 3-fold of upper limit value; the SCr \> 3.5 mg/dl or Ccr \< 30 ml/min);
- Previous surgery history in last 3 months;
- Patients with life expectancy \< 12 months
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2021
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT03462628
Start Date
April 24 2018
End Date
August 17 2021
Last Update
May 4 2022
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, China