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Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL) (PIVoTAL)

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ClinicalTrials.gov Identifier: NCT03057548
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Arash Aryana, MD, Sacramento EP Research

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Chronic Persistent Atrial Fibrillation Procedure: Cryo or RF Ablation only of Pulmonary Veins Procedure: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW Not Applicable

Detailed Description:

Patients with persistent or long-standing persistent atrial fibrillation will be enrolled in this 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pulmonary Vein Isolation (PVI)

Cryoablation only of Pulmonary Veins

or

Radiofrequency ablation only of Pulmonary Veins

Pulmonary Vein Isolation (PVI) alone.

Procedure: Cryo or RF Ablation only of Pulmonary Veins

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

Other Names:
  • Artic Front Advance Cardiac Cryoablation System
  • FDA Approved Radiofrequency Ablation Catheter

Experimental: PVI & Posterior Left Atrial Ablation

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)

Procedure: Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW

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)

Other Names:
  • Cryoablation of Pulmonary Veins plus RF Ablation of PLAW
  • RF Ablation of Pulmonary Veins plus RF Ablation of PLAW




Primary Outcome Measures :
  1. 1-year freedom from recurrent atrial arrhythmias [ Time Frame: One year ]
    Number of patients with recurrent atrial arrhythmias following catheter ablation


Secondary Outcome Measures :
  1. Overall complication rate [ Time Frame: During follow-up, assessed for an estimated total of one year. ]
    The type and frequency of complications following catheter ablation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057548


Contacts
Contact: Arash Aryana, MD 916-453-2684 a_aryana@outlook.com

Locations
United States, California
Mercy General Hospital and Dignity Health Heart and Vascular Institute Recruiting
Sacramento, California, United States, 95819
Contact: Arash Aryana, MD    916-453-2684    a_aryana@outlook.com   
Sponsors and Collaborators
Arash Aryana, MD
Investigators
Principal Investigator: Arash Aryana, MD Mercy General Hospital and Dignity Health Heart and Vascular Institute

Responsible Party: Arash Aryana, MD, Cardiac Electrophysiologist / Principal Investigator, Sacramento EP Research
ClinicalTrials.gov Identifier: NCT03057548     History of Changes
Other Study ID Numbers: PIVotal-01
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arash Aryana, MD, Sacramento EP Research:
Atrial Fibrillation
Long-Standing Atrial Fibrillation
Posterior Left Atrial Wall Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes