Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 98
- Locations
- 2
- Primary Endpoint
- Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Study Overview
Brief Summary
The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.
Detailed Description
Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.
In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 and <80 years
- •Symptomatic paroxysmal atrial fibrillation
- •Drug-refractory
- •Anticoagulation
Exclusion Criteria
- •Hyperthyreosis
- •Moderate-to-severe mitral valve valvulopathy
- •LV-ejection fraction <35%
- •Prior ablation, PCI or heart surgery <3 months
- •Left atrial thrombus
Outcomes
Primary Outcomes
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Time Frame: Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation
Secondary Outcomes
No secondary outcomes reported
