NCT03026413CompletedNot Applicable
The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial
The First Affiliated Hospital with Nanjing Medical University0 sites180 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Primary Endpoint
- any recorded atrial arrhythmias proved by 7-day holter
Study Overview
Brief Summary
To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.
Detailed Description
This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with paroxysmal atrial fibrillation refractory to drugs
- •with consent
Exclusion Criteria
- •LVEF<50%
- •history of cardiac surgery
- •valvular heart disease
- •abnormal thyroid function
- •left atrial thrombus
Arms & Interventions
PVAM
Experimental
pulomonary vein antrum modification with contact force monitoring for AF
Intervention: pulmonary vein antrum modification (Procedure)
Control arm
Active Comparator
pulmonary vein isolation without contact force
Intervention: pulmonary vein antrum modification (Procedure)
Outcomes
Primary Outcomes
any recorded atrial arrhythmias proved by 7-day holter
Time Frame: at least 18 months follow up
sustained at least 30s
Secondary Outcomes
- procedure time(time during patient enrollment)
- x ray time(time during patient enrollment)
- adverse event(at least 18 months follow up)
Investigators
Minglong Chen
Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology
The First Affiliated Hospital with Nanjing Medical University
Similar Trials
Unknown
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