Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (FULL CONTACT)

German Heart Center Munich

Status: Completed

Conditions: Improving Outcome After Pulmonary Vein Isolation

Treatments: Other: Pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT02816268

GER-EP-DHM-21

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Conventional Pulmonary vein isolation

Other group

Description:

Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter

Treatment:

Other: Pulmonary vein isolation

Contact force pulmonary vein isolation

Other group

Description:

Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)

Treatment:

Other: Pulmonary vein isolation