Clinical Trials Logo

Clinical Trial Summary

This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.


Clinical Trial Description

A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02654353
Study type Interventional
Source Johannes Gutenberg University Mainz
Contact
Status Completed
Phase Phase 4
Start date February 2012
Completion date December 2015

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Withdrawn NCT02344394 - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation N/A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