An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
Primary Purpose
Congestive Heart Failure
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
AV-node ablation
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Ventricular dyssynchrony
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Percentage of biventricular stimulated heart cycles
Secondary Outcome Measures
Combined endpoint of worsening of heart failure, NYHA class, 6-minute walking distance, and hospitalisation for heart failure, death or heart transplantation
Full Information
NCT ID
NCT00260546
First Posted
November 29, 2005
Last Updated
September 29, 2011
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00260546
Brief Title
An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
Official Title
An-Art Study: AV-Node Ablation in Cardiac Resynchronisation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled for 6 months.
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Ventricular dyssynchrony
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
AV-node ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of biventricular stimulated heart cycles
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, M.D.
Organizational Affiliation
University Hospital Basel, Cardiology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
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