Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy

This study has been withdrawn prior to enrollment.
(No patients enrolled for 6 months.)
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00260546
First received: November 29, 2005
Last updated: September 29, 2011
Last verified: September 2011

November 29, 2005
September 29, 2011
May 2006
December 2008   (final data collection date for primary outcome measure)
Percentage of biventricular stimulated heart cycles [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Percantage of biventricular stimulated heart cycles
Complete list of historical versions of study NCT00260546 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
a) Combined endpoint of worsening of heart failure, NYHA class,6-minute walking distance, and hospitalisation for heart failure, death or heart transplantation
Not Provided
Not Provided
 
An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
An-Art Study: AV-Node Ablation in Cardiac Resynchronisation Therapy

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Procedure: AV-node ablation
Patients that are randomized to AV node ablation will have their AV-node ablated using a transfemoral approach. Concurrently,a back-up pacing lead will temporarily be placed in the right ventricle.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients who had a CRT pacemaker or CRT-ICD implanted and who are under optimal medical therapy, can be included 3 months after implantation of the device.

Exclusion Criteria:

  • The sole exclusion criterion is no consent of the patient.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00260546
159/05
No
Christian Sticherling, MD, University Hospital Basel
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Christian Sticherling, M.D. University Hospital Basel, Cardiology
University Hospital, Basel, Switzerland
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP