Back to resultsAtrial Fibrillation Recurrence After Cryoballoon Ablation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of the Achieve catheter followed by ICE-guided mapping catheter
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Cryoballoon Ablation
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
- At least 18 years old
- Able to read and understand informed consent
Exclusion Criteria:
- Unable to give informed consent
Sites / Locations
- UPMC Presbyterian Shadyside
- UPMC Passavant
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Recurrent Atrial Fibrillation
Arm Description
Outcomes
Primary Outcome Measures
Presence or absence of pulmonary vein isolation or reconnection
Secondary Outcome Measures
Full Information
NCT ID
NCT01772030
First Posted
January 16, 2013
Last Updated
February 10, 2020
Sponsor
University of Pittsburgh
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01772030
Brief Title
Atrial Fibrillation Recurrence After Cryoballoon Ablation
Official Title
Mechanisms and Patterns of Atrial Fibrillation Recurrence After Cryoballoon Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 7, 2019 (Actual)
Study Completion Date
August 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to evaluate the mechanisms of recurrent atrial fibrillation after cryoballoon ablation using the Arctic Front Ablation System. For those with pulmonary vein reconnection, specific sites of reconnection will be evaluated with left atrial intracardiac echo (ICE) guidance. The Achieve mapping catheter will be evaluated head-to-head with our current method of ICE-guided recordings from a conventional mapping catheter with high output pulmonary venous pacing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial Fibrillation, Cryoballoon Ablation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recurrent Atrial Fibrillation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Use of the Achieve catheter followed by ICE-guided mapping catheter
Primary Outcome Measure Information:
Title
Presence or absence of pulmonary vein isolation or reconnection
Time Frame
During repeat cryoballoon ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing re-do catheter ablation procedure after index procedure with cryoballoon ablation
At least 18 years old
Able to read and understand informed consent
Exclusion Criteria:
Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep K Jain, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
12. IPD Sharing Statement
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Atrial Fibrillation Recurrence After Cryoballoon Ablation
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