Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL) (PIVoTAL)
Primary Purpose
Atrial Fibrillation Chronic, Persistent Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cryo or RF Ablation only of Pulmonary Veins
Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation Chronic focused on measuring Atrial Fibrillation, Long-Standing Atrial Fibrillation, Posterior Left Atrial Wall Ablation
Eligibility Criteria
Inclusion Criteria:
- Males and females with an age >18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
- All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
- Patients must be in AF on the day of the procedure
Exclusion Criteria:
- Any reversible cause of AF (post-operative, thyroid disorder, etc)
- Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
- Patients with any corrected or uncorrected congenital heart disease
- Patients with a history of hypertrophic cardiomyopathy
- Patients with cardiomyopathy and a left ventricular ejection fraction <35%
- Congestive heart failure, class IV
- Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
- Patients whose life expectancy is <1 year
- History of left-sided left atrial ablation (catheter or surgically-based)
- Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Sites / Locations
- Mercy General Hospital and Dignity Health Heart and Vascular Institute
- Heart Center, Japan Red Cross Yokohama-city Bay Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pulmonary Vein Isolation (PVI)
PVI & Posterior Left Atrial Ablation
Arm Description
Cryoablation only of Pulmonary Veins or Radiofrequency ablation only of Pulmonary Veins Pulmonary Vein Isolation (PVI) alone.
Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall or Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW)
Outcomes
Primary Outcome Measures
1-year freedom from recurrent atrial arrhythmias
Number of patients with recurrent atrial arrhythmias following catheter ablation
Secondary Outcome Measures
Overall complication rate
The type and frequency of complications following catheter ablation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03057548
Brief Title
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
Acronym
PIVoTAL
Official Title
Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
May 13, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arash Aryana, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone.
The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
Detailed Description
Patients with persistent or long-standing persistent atrial fibrillation will be enrolled in this multi-center, randomized, prospective, single-blinded study. All patients are required to be in atrial fibrillation (AF) on the day of the ablation procedure. After ablation (isolation) of the pulmonary veins (PVI) is complete, and while still in the electrophysiology lab, all patients are randomized to either PVI, alone [Group 1] or the combination of PVI plus ablation of the posterior left atrial wall (PLAW) [Group 2]. For those patients randomized to PVI, their ablation procedure is complete at this time. For those patients randomized to PVI plus PLAW, they will have the additional ablation to the posterior left atrial wall performed.
All study patients have the same follow-up after their ablation procedure: clinic visits at 3, 6, and 13 months; a heart event monitor is worn for 7-14 days before these visits. An echocardiogram is done at 4-6 months after the ablation procedure. Blood thinners are usually recommended for three months after the ablation procedure and then the need for continued use of blood thinners will be based on individual patient's medical history, stroke risk and the judgement of their study doctor. Information about patient's medical history, heart arrhythmias, and atrial fibrillation will be collected during the study. This information will be analyzed as part of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Chronic, Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Long-Standing Atrial Fibrillation, Posterior Left Atrial Wall Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary Vein Isolation (PVI)
Arm Type
Active Comparator
Arm Description
Cryoablation only of Pulmonary Veins
or
Radiofrequency ablation only of Pulmonary Veins
Pulmonary Vein Isolation (PVI) alone.
Arm Title
PVI & Posterior Left Atrial Ablation
Arm Type
Experimental
Arm Description
Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
or
Radiofrequency ablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
PVI ablation plus ablation of the Posterior Left Atrial Wall (PLAW)
Intervention Type
Procedure
Intervention Name(s)
Cryo or RF Ablation only of Pulmonary Veins
Other Intervention Name(s)
Artic Front Advance Cardiac Cryoablation System, FDA Approved Radiofrequency Ablation Catheter
Intervention Description
Artic Front Advance Cardiac Cryoabltion System used to ablate the Pulmonary Veins
OR
FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
Ablation of the Pulmonary Veins alone
Intervention Type
Procedure
Intervention Name(s)
Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW
Other Intervention Name(s)
Cryoablation of Pulmonary Veins plus RF Ablation of PLAW, RF Ablation of Pulmonary Veins plus RF Ablation of PLAW
Intervention Description
Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW
OR
RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW
Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)
Primary Outcome Measure Information:
Title
1-year freedom from recurrent atrial arrhythmias
Description
Number of patients with recurrent atrial arrhythmias following catheter ablation
Time Frame
One year
Secondary Outcome Measure Information:
Title
Overall complication rate
Description
The type and frequency of complications following catheter ablation
Time Frame
During follow-up, assessed for an estimated total of one year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females with an age >18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
Patients must be in AF on the day of the procedure
Exclusion Criteria:
Any reversible cause of AF (post-operative, thyroid disorder, etc)
Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
Patients with any corrected or uncorrected congenital heart disease
Patients with a history of hypertrophic cardiomyopathy
Patients with cardiomyopathy and a left ventricular ejection fraction <35%
Congestive heart failure, class IV
Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure
Patients whose life expectancy is <1 year
History of left-sided left atrial ablation (catheter or surgically-based)
Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Aryana, MD
Organizational Affiliation
Mercy General Hospital and Dignity Health Heart and Vascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy General Hospital and Dignity Health Heart and Vascular Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Heart Center, Japan Red Cross Yokohama-city Bay Hospital
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
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