Clinical Trials Logo
  1. Home
  2. Persistent Atrial Fibrillation
  3. NCT03057548

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

Persistent Atrial Fibrillation Clinical Trial

Official title:
Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation for Treatment of Persistent Atrial Fibrillation (PIVoTAL) Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03057548
Study type Interventional
Source Sacramento EP Research
Contact
Status Completed
Phase N/A
Start date February 24, 2017
Completion date May 31, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT03650556 - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation N/A
Recruiting NCT04085731 - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn NCT02344394 - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation N/A
Completed NCT01694563 - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation N/A
Terminated NCT01683045 - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats N/A
Active, not recruiting NCT03643224 - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation N/A
Withdrawn NCT05093868 - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF) N/A
Completed NCT05152966 - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II) N/A
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting NCT06124690 - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation N/A
Not yet recruiting NCT05454111 - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation N/A
Active, not recruiting NCT05077670 - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn NCT03835338 - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm N/A
Completed NCT02275104 - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy N/A
Not yet recruiting NCT05565183 - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation. N/A
Completed NCT02274857 - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures N/A