Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260546
Status:
WITHDRAWN
Last Update Posted:
2011-09-30
First Post:
2005-11-29
Brief Title:
An-Art Study Atrioventricular AV Node Ablation in Cardiac Resynchronisation Therapy
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
An-Art Study AV-Node Ablation in Cardiac Resynchronisation Therapy
Status:
WITHDRAWN
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients enrolled for 6 months
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiac resynchronisation therapy CRT is a highly effective treatment option for patients with symptomatic heart failure and electrical intraventricular dyssynchrony who are unresponsive to medical therapy CRT has been shown to improve the quality of life in these patients and lately two studies had shown a mortality reduction with and without the adjunct of an implantable cardioverter defibrillator ICD Unfortunately up to 25 of the CRT recipients do not show a symptomatic improvement after device implantation non-responder Because of possible intermittent tachycardiac intrinsic conduction it remains difficult in numerous patients to assure a 100 biventricular stimulation as the prerequisite for a beneficial therapeutic effect In a important study by Knight et al it could be shown that in a population of 440 CRT-patients 36 did not have continuous biventricular stimulation The main cause was the occurrence of atrial tachyarrhythmias in particular atrial fibrillation The medical control of rapid ventricular conduction remains a difficult problem in heart failure patients Furthermore it is unknown how many patients have good biventricular pacing under resting conditions but develop an improved AV-conduction with exercise This can cause inhibition of ventricular stimulation or in many cases fusion beats Conversely an AV-interval programmed too short may have detrimental effects on diastolic filling times
The safest method to control the ventricular rate and prevent ventricular fusion beats with a normal AV time is the AV node ablation using radiofrequency ablation
The An Art Study investigates whether patients with an implanted CRT pacemaker or a CRT defibrillator will benefit from an AV-node-ablation using a combined symptomatic heart failure endpoint and duration of biventricular stimulation as compared to a CRT control group
The safest method to control the ventricular rate and prevent ventricular fusion beats with a normal AV time is the AV node ablation using radiofrequency ablation
The An Art Study investigates whether patients with an implanted CRT pacemaker or a CRT defibrillator will benefit from an AV-node-ablation using a combined symptomatic heart failure endpoint and duration of biventricular stimulation as compared to a CRT control group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None