An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
|ClinicalTrials.gov Identifier: NCT00260546|
Recruitment Status : Withdrawn (No patients enrolled for 6 months.)
First Posted : December 1, 2005
Last Update Posted : September 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure||Procedure: AV-node ablation||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An-Art Study: AV-Node Ablation in Cardiac Resynchronisation Therapy|
|Study Start Date :||May 2006|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2008|
Procedure: AV-node ablation
- Percentage of biventricular stimulated heart cycles [ Time Frame: 2 years ]
- Combined endpoint of worsening of heart failure, NYHA class, 6-minute walking distance, and hospitalisation for heart failure, death or heart transplantation [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260546
|Principal Investigator:||Christian Sticherling, M.D.||University Hospital Basel, Cardiology|