Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation (FULL CONTACT)
Primary Purpose
Improving Outcome After Pulmonary Vein Isolation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Improving Outcome After Pulmonary Vein Isolation
Eligibility 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
Sites / Locations
- Deutsches Herzzentrum München
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Conventional Pulmonary vein isolation
Contact force pulmonary vein isolation
Arm Description
Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter
Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)
Outcomes
Primary Outcome Measures
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
Secondary Outcome Measures
Time to first documented recurrence of atrial fibrillation
Complications due to ablation
Number of reconnected pulmonary veins
Full Information
NCT ID
NCT02816268
First Posted
June 24, 2016
Last Updated
June 27, 2016
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT02816268
Brief Title
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Acronym
FULL CONTACT
Official Title
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improving Outcome After Pulmonary Vein Isolation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Pulmonary vein isolation
Arm Type
Other
Arm Description
Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter
Arm Title
Contact force pulmonary vein isolation
Arm Type
Other
Arm Description
Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)
Intervention Type
Other
Intervention Name(s)
Pulmonary vein isolation
Primary Outcome Measure Information:
Title
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
Time Frame
20min after procedure
Secondary Outcome Measure Information:
Title
Time to first documented recurrence of atrial fibrillation
Time Frame
12 month
Title
Complications due to ablation
Time Frame
30 days
Title
Number of reconnected pulmonary veins
Time Frame
12 month
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
80636
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
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