Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL) (PIVoTAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03057548|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2017
Last Update Posted : May 19, 2020
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||June 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Pulmonary Vein Isolation (PVI)
Cryoablation only of Pulmonary Veins
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
FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
Ablation of the Pulmonary Veins alone
Experimental: PVI & Posterior Left Atrial Ablation
Cryoablation of Pulmonary Veins plus RF ablation of Posterior Left Atrial Wall
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
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)
- 1-year freedom from recurrent atrial arrhythmias [ Time Frame: One year ]Number of patients with recurrent atrial arrhythmias following catheter ablation
- 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
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
|United States, California|
|Mercy General Hospital and Dignity Health Heart and Vascular Institute|
|Sacramento, California, United States, 95819|
|Heart Center, Japan Red Cross Yokohama-city Bay Hospital|
|Principal Investigator:||Arash Aryana, MD||Mercy General Hospital and Dignity Health Heart and Vascular Institute|