Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation
August 27, 2022 updated by: Universitätsklinikum Hamburg-Eppendorf
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
102
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
-
-
-
Hamburg, Germany, 20246
- University Hospital Hamburg
-
-
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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Loss of pace capture
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 |
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
|
|
ACTIVE_COMPARATOR: Conventional
Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation |
catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to AF and AT recurrence
Time Frame: 12 months
|
recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
procedure duration
Time Frame: completed (15 months)
|
time needed to complete the procedure
|
completed (15 months)
|
|
procedure safety
Time Frame: up to three days after the procedure
|
complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
|
up to three days after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephan Willems, Universitäres Herzzentrum Hamburg GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2012
Study Registration Dates
First Submitted
November 4, 2012
First Submitted That Met QC Criteria
November 6, 2012
First Posted (ESTIMATE)
November 9, 2012
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 27, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV3503
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.