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

June 27, 2016 updated by: Deutsches Herzzentrum Muenchen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Deutsches Herzzentrum München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
Time Frame: 20min after procedure
20min after procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first documented recurrence of atrial fibrillation
Time Frame: 12 month
12 month
Complications due to ablation
Time Frame: 30 days
30 days
Number of reconnected pulmonary veins
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Estimate)

June 28, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-EP-DHM-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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