Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVI Plus Catheter Ablation
PVI Alone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
(Step 1 - Registration)
- The subject is 18 years of age or older
- Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
- performed within 6 months)
- Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
- Provided written informed consent
- Be eligible for an AF ablation procedure for Paroxysmal AF
(Step 2 - Randomization)
- Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation
Exclusion Criteria:
(Step 1 - Registration)
- Pregnant or planning to become pregnant during study
- Co-morbid medical conditions that limit one-year life expectancy
- Previous cardiac surgery
- Patients who have active infection or sepsis
- Patients with esophageal ulcers strictures and varices
- Patients who are contraindicated for anticoagulants such as heparin and warfarin
- Patients who are being treated for ventricular arrhythmias
- Patients who have had a previous left atrial catheter ablation for AF (does not
- include ablation for AFL or other supraventricular arrhythmias)
- Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
- Not competent to legally represent him or herself (e.g., requires a guardian or
- caretaker as a legal representative)
(Step 2 Randomization)
- Not able to receive additional linear or focal intracardiac catheter ablation
Sites / Locations
- Aurora Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PVI Plus Catheter Ablation
PVI Alone
Arm Description
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Outcomes
Primary Outcome Measures
Time to recurrence
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
Secondary Outcome Measures
Time to recurrence following intervention
Time to recurrence following intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03115554
Brief Title
Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
Official Title
Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Patients did not want to be randomized in their procedure.
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aurora Health Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVI Plus Catheter Ablation
Arm Type
Active Comparator
Arm Description
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Arm Title
PVI Alone
Arm Type
Active Comparator
Arm Description
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Intervention Type
Procedure
Intervention Name(s)
PVI Plus Catheter Ablation
Intervention Description
Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
Intervention Type
Procedure
Intervention Name(s)
PVI Alone
Intervention Description
Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
Primary Outcome Measure Information:
Title
Time to recurrence
Description
Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to recurrence following intervention
Description
Time to recurrence following intervention
Time Frame
12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(Step 1 - Registration)
The subject is 18 years of age or older
Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view
performed within 6 months)
Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III)
Provided written informed consent
Be eligible for an AF ablation procedure for Paroxysmal AF
(Step 2 - Randomization)
Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation
Exclusion Criteria:
(Step 1 - Registration)
Pregnant or planning to become pregnant during study
Co-morbid medical conditions that limit one-year life expectancy
Previous cardiac surgery
Patients who have active infection or sepsis
Patients with esophageal ulcers strictures and varices
Patients who are contraindicated for anticoagulants such as heparin and warfarin
Patients who are being treated for ventricular arrhythmias
Patients who have had a previous left atrial catheter ablation for AF (does not
include ablation for AFL or other supraventricular arrhythmias)
Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
Not competent to legally represent him or herself (e.g., requires a guardian or
caretaker as a legal representative)
(Step 2 Randomization)
Not able to receive additional linear or focal intracardiac catheter ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasbir Sra, MD
Organizational Affiliation
Aurora Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation
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