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

Improving Outcome After Pulmonary Vein Isolation Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816268
• Other study ID #: GER-EP-DHM-21
• Status: Completed
• Phase: N/A
• First received: June 24, 2016
• Last updated: June 27, 2016
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Improving Outcome After Pulmonary Vein Isolation

Intervention

Other:
• Pulmonary vein isolation

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reconnected pulmonary vein after ablation and a waíting period of 20min		20min after procedure	Yes
Secondary	Time to first documented recurrence of atrial fibrillation		12 month	Yes
Secondary	Complications due to ablation		30 days	Yes
Secondary	Number of reconnected pulmonary veins		12 month	Yes