Back to resultsA New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
Primary Purpose
Persistent Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Persistent atrial fibrillation, catheter ablation, outcome
Eligibility Criteria
Inclusion Criteria:
- persistent atrial fibrillation lasting longer than 3 months
- no previous ablations
- at least 1 electrical cardioversion
Exclusion Criteria:
- non-persistent atrial fibrillation
- previous ablation procedures
Sites / Locations
- University Hospital Mainz, Department of Medicine II
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Group A: stepwise ablation
Group B: sequential substrate ablation
Arm Description
Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach
Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation
Outcomes
Primary Outcome Measures
Number of patients without any arrhythmias during follow-up of 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT02654353
First Posted
January 9, 2016
Last Updated
January 12, 2016
Sponsor
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT02654353
Brief Title
A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
Official Title
A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.
Detailed Description
A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Persistent atrial fibrillation, catheter ablation, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: stepwise ablation
Arm Type
Other
Arm Description
Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach
Arm Title
Group B: sequential substrate ablation
Arm Type
Active Comparator
Arm Description
Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation
Intervention Type
Procedure
Intervention Name(s)
Ablation
Intervention Description
In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.
Primary Outcome Measure Information:
Title
Number of patients without any arrhythmias during follow-up of 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
persistent atrial fibrillation lasting longer than 3 months
no previous ablations
at least 1 electrical cardioversion
Exclusion Criteria:
non-persistent atrial fibrillation
previous ablation procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rostock, MD
Organizational Affiliation
University Hospital Mainz, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Mainz, Department of Medicine II
City
Mainz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach
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