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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
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Improving Outcome After Pulmonary Vein Isolation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

First Posted
June 24, 2016
Last Updated
June 27, 2016
Sponsor
Deutsches Herzzentrum Muenchen
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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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