Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Primary Purpose
Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
catheter based pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- written informed consent
- age > 18 years
- paroxysmal atrial fibrillation
Exclusion Criteria:
- structural heart disease
- intracardiac thrombus
- reversible causes of atrial fibrillation
- inability to take warfarin
Sites / Locations
- University Hospital Hamburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Loss of pace capture
Conventional
Arm Description
Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation
Outcomes
Primary Outcome Measures
time to AF and AT recurrence
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
Secondary Outcome Measures
procedure duration
time needed to complete the procedure
procedure safety
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
Full Information
NCT ID
NCT01724437
First Posted
November 4, 2012
Last Updated
August 27, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT01724437
Brief Title
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Official Title
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
5. Study Description
Brief Summary
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Detailed Description
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loss of pace capture
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved
catheter based pulmonary vein isolation
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.
catheter based pulmonary vein isolation
Intervention Type
Device
Intervention Name(s)
catheter based pulmonary vein isolation
Intervention Description
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
Primary Outcome Measure Information:
Title
time to AF and AT recurrence
Description
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
Time Frame
12 months
Secondary Outcome Measure Information:
Title
procedure duration
Description
time needed to complete the procedure
Time Frame
completed (15 months)
Title
procedure safety
Description
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
Time Frame
up to three days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
written informed consent
age > 18 years
paroxysmal atrial fibrillation
Exclusion Criteria:
structural heart disease
intracardiac thrombus
reversible causes of atrial fibrillation
inability to take warfarin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems
Organizational Affiliation
Universitäres Herzzentrum Hamburg GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23644091
Citation
Steven D, Sultan A, Reddy V, Luker J, Altenburg M, Hoffmann B, Rostock T, Servatius H, Stevenson WG, Willems S, Michaud GF. Benefit of pulmonary vein isolation guided by loss of pace capture on the ablation line: results from a prospective 2-center randomized trial. J Am Coll Cardiol. 2013 Jul 2;62(1):44-50. doi: 10.1016/j.jacc.2013.03.059. Epub 2013 May 1.
Results Reference
derived
Learn more about this trial
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
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