Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816268
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Improving Outcome After Pulmonary Vein Isolation Other: Pulmonary vein isolation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Study Start Date : September 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of reconnected pulmonary vein after ablation and a waíting period of 20min [ Time Frame: 20min after procedure ]

Secondary Outcome Measures :
  1. Time to first documented recurrence of atrial fibrillation [ Time Frame: 12 month ]
  2. Complications due to ablation [ Time Frame: 30 days ]
  3. Number of reconnected pulmonary veins [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816268


Locations
Layout table for location information
Germany
Deutsches Herzzentrum München
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

Layout table for additonal information
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT02816268     History of Changes
Other Study ID Numbers: GER-EP-DHM-21
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes