Ventricular TachycardiaABLATION 4 ICDNCT00481377
Ablation for ICD Intervention Reduction in Patients With CAD
A study testing ablation in people with Ventricular Tachycardia and Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Coronary Artery Disease, Implantable Cardioverter-Defibrillator
- What is being tested?
- ablation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- May 2007to May 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary Artery Disease
- ICD implanted
- Appropriate ICD intervention during the 3 months prior to enrollment
- Coronary angiography during the 6 months prior to enrollment
- Possible revascularization
- Age over 18 years
- Signed informed consent
Who cannot join
- Age less then 18 years
- Pregnancy
- Active participation in other trial
- Heart failure (NYHA IV)
- Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
- Monomorphic, incessant, ventricular tachycardia
- Revascularization or other cardio-surgical procedure scheduled in the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.
- Being tested
- ablation
- Keywords
- Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions
- Medical subject headings
- Tachycardia, Ventricular, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of appropriate ICD interventions
Secondary outcomes (4)
Overall mortality
Cardiac mortality
Hospitalization due to arrhythmia or heart failure
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMay 2007
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Lukasz J Szumowski, MD, PhD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481377
- Sponsor's protocol ID
- IK-NP-0021-42/1013/07
- Acronym
- ABLATION 4 ICD
- Status last verified
- Jul 2008
- First submitted
- 30 May 2007
- Last updated
- 21 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Szumowski L, Przybylski A, Maciag A, Derejko P, Bodalski R, Zakrzewska J, Orczykowski M, Szufladowicz E, Szwed H, Walczak F. Outcomes of a single centre registry of patients with ischaemic heart disease, qualified for an RF ablation of ventricular arrhythmia after ICD intervention. Kardiol Pol. 2009 Feb;67(2):123-7; discussion 128-9. English, Polish.
PubMed 19288374
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00481377
- Acronym / sponsor ID
- ABLATION 4 ICD / IK-NP-0021-42/1013/07
- Keywords
- Ablation, Ventricular tachycardia, coronary artery disease, Implantable cardioverter defibrillator interventions
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- May 2007
- Study completion
- May 2010 (estimated)
- First posted
- 1 Jun 2007 (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.
The aim of this study is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Coronary Artery Disease
- ICD implanted
- Appropriate ICD intervention during the 3 months prior to enrollment
- Coronary angiography during the 6 months prior to enrollment
- Possible revascularization
Key exclusion criteria (7 listed)
- Age less then 18 years
- Pregnancy
- Active participation in other trial
- Heart failure (NYHA IV)
- Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
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 |
|---|---|---|
| ablation | Procedure or surgery | – |
Primary outcome
Number of appropriate ICD interventions
4 secondary outcomes
Overall mortality
Cardiac mortality
Hospitalization due to arrhythmia or heart failure
Quality of life
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2008.
- Derived from this study: PubMed 19288374Szumowski L, Przybylski A, Maciag A, Derejko P, Bodalski R, Zakrzewska J, Orczykowski M, Szufladowicz E, Szwed H, Walczak F. Outcomes of a single centre registry of patients with ischaemic heart disease, qualified for an RF ablation of ventricular arrhythmia after ICD intervention. Kardiol Pol. 2009 Feb;67(2):123-7; discussion 128-9. English, Polish.
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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.
Lukasz J Szumowski, MD, PhD principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ablation in people with Ventricular Tachycardia and Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Number of appropriate ICD interventions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00481377, which also lists 1 linked publication.
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 21 Jul 2008.