Congestive Heart FailureEarly Phase 1NCT00260546
An-Art Study: Atrioventricular (AV) Node Ablation in Cardiac Resynchronisation Therapy
A Early Phase 1 study testing AV-node ablation in people with Congestive Heart Failure, run by University Hospital, Basel, Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- AV-node ablation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Dec 2008
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The sole exclusion criterion is no consent of the patient.
About this study
Official title: 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.
- Conditions
- Congestive Heart Failure
- Being tested
- AV-node ablation
- Keywords
- Ventricular dyssynchrony
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-node ablationProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of biventricular stimulated heart cycles
Measured: 2 years
Secondary outcomes (1)
Combined endpoint of worsening of heart failure, NYHA class, 6-minute walking distance, and hospitalisation for heart failure, death or heart transplantation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startMay 2006
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: No patients enrolled for 6 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Christian Sticherling, M.D., Principal investigator, University Hospital Basel, Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260546
- Sponsor's protocol ID
- 159/05
- Status last verified
- Sep 2011
- First submitted
- 29 Nov 2005
- Last updated
- 30 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An-Art Study: AV-Node Ablation in Cardiac Resynchronisation Therapy
- ClinicalTrials.gov ID
- NCT00260546
- Acronym / sponsor ID
- 159/05
- Conditions
- Congestive Heart Failure
- Keywords
- Ventricular dyssynchrony
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled for 6 months.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The sole exclusion criterion is no consent of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-node ablationPatients 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. | Procedure or surgery | – |
Primary outcome
Percentage of biventricular stimulated heart cycles
Time frame: 2 years
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Sticherling, M.D. principal investigator
University Hospital Basel, Cardiology
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AV-node ablation in people with Congestive Heart Failure, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of biventricular stimulated heart cycles (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2011.