Ventricular TachycardiansVTNCT03147027
Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
An observational study of Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy, Reduced LVEF
- What is being tested?
- VT ablation and medication
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2017to Dec 2020
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF
Who may be able to join
- left ventricular ejection fraction (TTE or MRI) ≤40%
- diagnosed ischemic heart disease
- nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring
- ICD implantation with primary preventive indication
Who cannot join
- ICD implantation within 2 months
- previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
- no written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Hisaki Makimoto, MD
Rabea Wagstaff, M.A.
About this study
Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.
- Being tested
- VT ablation, medication
- Keywords
- ischemic cardiomyopathy, prophylactic ablation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT ablationProcedure or surgery
Substrate mapping for VT will be performed with the CARTO electroanatomical system.
medicationOther
medication to prevent sustained VT and ICD therapies
| Study group | Role | What they receive |
|---|---|---|
| VT ablation group | Not described Receives: Procedure: VT ablation | |
| medication group | Not described Receives: Other: medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of sustained VT/VF or ICD therapy
occurrence of sustained VT/VF or ICD therapy including ATP and shock
Measured: time from randomization to occurrence of any sustained VT/VF within 24 months
Secondary outcomes (2)
survival free from clinical events
survival free from clinical events (death, syncope, hospital admission due to cardiac problems, and VT storm, defined as more than three VT episodes in 24 hours)
Measured: time from randomization to 24 months
number of appropriate ICD therapies
number of appropriate ICD therapies (ATP or shock)
Measured: time from randomization to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start2 May 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147027
- Sponsor's protocol ID
- 15-007
- Acronym
- nsVT
- Status last verified
- Jun 2020
- First submitted
- 5 May 2017
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation for Nonsustained Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03147027
- Acronym / sponsor ID
- nsVT / 15-007
- Keywords
- ischemic cardiomyopathy, prophylactic ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
Despite established implantable cardioverter-defibrillator (ICD) therapy and catheter ablation for sustained ventricular tachycardia (VT) in patients with ischemic heart disease (IHD) and reduced left ventricular ejection fraction (LVEF), the efficacy of catheter ablation in patients with nonsustained VT has been not yet clarified. The incidence of appropriate ICD therapy itself has been reported to be a worse prognostic factor in patients with reduced LVEF. Therefore theoretically the inhibition of these ventricular incidences can result in the prognostic improvement.To suppress ventricular arrhythmias aside from antiarrhythmic agents, catheter ablation has been developed prominently in this decade along with the technological improvement such as irrigated ablation catheters, three-dimensional mapping systems, multi-polar catheters, and image integration system with CT and MRI. The rationale of this trial is to study the efficacy of the eradication of arrhythmogenic substrate in ischemic cardiomyopathy with reduced LVEF and nonsustained VT on prevention of the occurrence of sustained VT/VF and ICD therapies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VT ablation group | – | Procedure: VT ablation |
| medication group | – | Other: medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with nonsustained VT and ischemic cardiomyopathy and reduced LVEF
Key inclusion criteria (4 listed)
- left ventricular ejection fraction (TTE or MRI) ≤40%
- diagnosed ischemic heart disease
- nonsustained monomorphic VT with more than 5 beats in the record of the implantable cardioverter-defibrillator or in any means of electrocardiogram (ECG) including ECG monitor and holter monitoring
- ICD implantation with primary preventive indication
Key exclusion criteria (3 listed)
- ICD implantation within 2 months
- previously documented sustained VT/VF (over 30 seconds) or adequate ICD shock
- no written informed consent
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 |
|---|---|---|
| VT ablationSubstrate mapping for VT will be performed with the CARTO electroanatomical system. | Procedure or surgery | VT ablation group |
| medicationmedication to prevent sustained VT and ICD therapies | Other | medication group |
Primary outcome
occurrence of sustained VT/VF or ICD therapy
Time frame: time from randomization to occurrence of any sustained VT/VF within 24 months
occurrence of sustained VT/VF or ICD therapy including ATP and shock
2 secondary outcomes
survival free from clinical events
Time frame: time from randomization to 24 months
number of appropriate ICD therapies
Time frame: time from randomization to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hisaki Makimoto, MD (+492118118800, hisaki.makimoto@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of sustained VT/VF or ICD therapy (time frame: time from randomization to occurrence of any sustained VT/VF within 24 months). 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 25 Jun 2020.