Status:
UNKNOWN
CPVI Alone Versus. CPVI Plus Electrophysiological Substrate Ablation in the LA During SR for the Treatment of Non-PAF
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
Fudan University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this investigation is to compare the efficacy of two different AF ablation strategies in patients with non-paroxysmal AF: CPVI plus electrophysiologic substrate ablation in th...
Detailed Description
BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, which affects patients' morbidity and mortality. AF ablation has emerged as a promising treatment strategy, offering th...
Eligibility Criteria
Inclusion
- Patients age is 18-80 years;
- Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
- 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; and
- Patients who are pregnant.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03448562
Start Date
April 1 2018
End Date
September 30 2020
Last Update
February 11 2020
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000