Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

Not Applicable

Completed

• Conditions: Improving Outcome After Pulmonary Vein Isolation
• Interventions: Other: Pulmonary vein isolation

• Registration Number: NCT02816268
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-05
• Study Completion: 2015-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

• Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
• At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
• Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
• Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.

Exclusion Criteria

• Left atrial thrombus
• Contraindications for oral anticoagulation or adenosin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Pulmonary vein isolation	Pulmonary vein isolation	Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter
Contact force pulmonary vein isolation	Pulmonary vein isolation	Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)

Primary Outcome Measures

Name	Time	Method
Number of reconnected pulmonary vein after ablation and a waíting period of 20min	20min after procedure

Secondary Outcome Measures

Name	Time	Method
Time to first documented recurrence of atrial fibrillation	12 month
Complications due to ablation	30 days
Number of reconnected pulmonary veins	12 month

Trial Locations

Locations (1)

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany