RAte Control Efficacy in Permanent Atrial Fibrillation

Status Completed

Clinical Trial Summary

The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate <110 bpm.Strict rate control is defined as a mean resting heart rate < 80 beats per minute (bpm) and heart rate during minor exercise < 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.

Clinical Trial Description

Study objectives:

1. To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity

2. To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00392613
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Completed
Phase	N/A
Start date	January 2005

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Withdrawn	`NCT02344394` - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation	N/A
Terminated	`NCT01683045` - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats	N/A
Completed	`NCT01694563` - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation	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