Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: PVI Plus Catheter AblationProcedure: PVI Alone
- Registration Number
- NCT03115554
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
(Step 1 - Registration)
- The subject is 18 years of age or older
- Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
- performed within 6 months)
- Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
- Provided written informed consent
- Be eligible for an AF ablation procedure for Paroxysmal AF
(Step 2 - Randomization)
- Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation
(Step 1 - Registration)
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one-year life expectancy
- Previous cardiac surgery
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices
- Patients who are contraindicated for anticoagulants such as heparin and warfarin
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous left atrial catheter ablation for AF (does not
- include ablation for AFL or other supraventricular arrhythmias)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- Not competent to legally represent him or herself (e.g., requires a guardian or
- caretaker as a legal representative)
(Step 2 Randomization)
- Not able to receive additional linear or focal intracardiac catheter ablation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PVI Plus Catheter Ablation PVI Plus Catheter Ablation Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. PVI Alone PVI Alone Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
- Primary Outcome Measures
Name Time Method Time to recurrence 12 months Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
- Secondary Outcome Measures
Name Time Method Time to recurrence following intervention 12 months post intervention Time to recurrence following intervention
Trial Locations
- Locations (1)
Aurora Health Care
🇺🇸Milwaukee, Wisconsin, United States