The Role of Contact Force Sensing in Electrical Pulmonary Vein Isolation When Conducting Atrial Fibrillation Ablation
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Rate of Acute Pulmonary Vein Reconnection
Study Overview
Brief Summary
There are multiple important factors which need to be monitored when conducting ablation for atrial fibrillation. The contact between the catheter tip and the inside of the heart wall is now measurable and may improve the effectiveness of catheter ablation for atrial fibrillation patients.
Detailed Description
This study compares patients who have this procedure where this contact information is known (unblinded) versus those where the contact information is not known (blinded). The outcome is the rate of acute reconnection at 1 hour after achieving pulmonary vein isolation.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with symptomatic AF
Exclusion Criteria
- •Recent CVA
- •Contraindication to warfarin therapy
Arms & Interventions
Contact Force Known
Ablation with contact force data known
Intervention: Ablation (Procedure)
Contact Force Not Known
Contact Force data unavailable during ablation
Intervention: Ablation (Procedure)
Outcomes
Primary Outcomes
Rate of Acute Pulmonary Vein Reconnection
Time Frame: 1 hour post procedure
Secondary Outcomes
No secondary outcomes reported