Clinical Trials Logo

Clinical Trial Summary

The hypothesis of this study is that by facilitating reverse atrial remodeling with maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a simple pulmonary vein isolation (PVI) with results equivalent or superior to more complex atrial ablation for patients with persistent AF.


Clinical Trial Description

Atrial fibrillation (AF) is the most common cardiac disorder currently affecting 2.3 million U.S. adults with an expected increase in incidence to 5.6 million by the year 2050. Randomized clinical trials have shown that ablation was superior to antiarrhythmic drug (AAD) in maintaining sinus rhythm among patients with symptomatic predominantly paroxysmal AF. However the results for catheter ablation of persistent AF is much lower and more variable, ranging between 20-80%. Moreover there is no agreed-upon standard ablation approach. Prior studies suggest that pulmonary vein isolation (PVI) alone has an unacceptably low success rate so most laboratories supplement this approach with additional lesion sets. These include complex atrial fractionated electrograms ("CAFÉ"), autonomic denervation, and linear left atrial ablation at the roof and mitral isthmus, in an empirical manner or stepwise approach. However, these strategies are time consuming and prone to proarrhythmia, namely post-ablation atrial tachycardias which can occur with an incidence ranging from < 5 to 50%.

The lower efficacy of PVI alone in persistent AF has been attributed to adverse electrical, molecular, and structural remodeling of the atria. Collectively, atrial remodeling decreases conduction velocity and the effective refractory period, and results in a shortened atrial wavelength, which increases the number and stability of reentrant wavelets. This can cause persistence of AF independent of a focal discharge. Standard PVI addresses the "focal discharge" or trigger from the PVs that initiates AF but not necessarily the underlying atrial substrate.

Based on these concepts, we hypothesized that successful atrial reverse remodeling by temporary AAD therapy would facilitate the performance of PVI alone in patients with persistent AF. The utilization of reverse remodeling to enhance the efficiency, efficacy and safety of ablation of AF has not been tested in a randomized clinical trial. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01877473
Study type Interventional
Source Valley Health System
Contact
Status Withdrawn
Phase Phase 4
Start date May 2013
Completion date September 2013

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
Not yet recruiting NCT05454111 - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation N/A
Completed NCT06260670 - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With 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