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

NCT ID: NCT02816268

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Improving Outcome After Pulmonary Vein Isolation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Pulmonary vein isolation

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

Group Type OTHER

Pulmonary vein isolation

Intervention Type OTHER

Contact force pulmonary vein isolation

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

Group Type OTHER

Pulmonary vein isolation

Intervention Type OTHER

Interventions

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Pulmonary vein isolation

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Deutsches Herzzentrum München

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GER-EP-DHM-21

Identifier Type: -

Identifier Source: org_study_id

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