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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00260546
• Other study ID #: 159/05
• Status: Withdrawn
• Phase: Phase 0
• First received: November 29, 2005
• Last updated: September 29, 2011
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of biventricular stimulated heart cycles		2 years	No
Secondary	Combined endpoint of worsening of heart failure, NYHA class, 6-minute walking distance, and hospitalisation for heart failure, death or heart transplantation		2 years	No