Monomorphic Ventricular TachycardiaNCT03734562
Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia
A study testing Ablation and Antiarrhythmic drug in people with Monomorphic Ventricular Tachycardia, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monomorphic Ventricular Tachycardia
- What is being tested?
- Ablation and Antiarrhythmic drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2010to 30 Sep 2017
- 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
- Ischemic cardiomyopathy, with ischemic myocardial scar
- Sustained monomorphic ventricular tachycardia
- Age > 18 years
- Prior ICD implantation
Who cannot join
- VT storm
- NYHA functional class IV
- Additional indication for antiarrhythmic drug therapy
- Contraindication for both study drugs (amiodarone and sotalol).
- Uncontrolled myocardial ischemia.
- LV thrombus.
Show all 11Show fewer
- Non-ischemic VT substrate.
- Contraindications for anticoagulation.
- Prior substrate ablation in the previous 6 months
- Cr > 2.5 mg/dL
- Mitral AND aortic mechanical valvular prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks
To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.
Read the detailed description
Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.
- Conditions
- Monomorphic Ventricular Tachycardia
- Being tested
- Ablation, Antiarrhythmic drug
- Keywords
- Ventricular tachycardia, Ischemic cardiomyopathy, Catheter Ablation, Antiarrhythmic drug therapy, ICD
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Also called Catheter Ablation
Substrate-based radiofrequency catheter ablation
Antiarrhythmic drugDrug
Also called Amiodarone, Sotalol
Amiodarone or sotalol therapy
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Substrate-based radiofrequency catheter ablation Receives: Procedure: Ablation |
| Antiarrhythmic drug therapy | Active comparator | Antiarrhythmic drug therapy; amiodarone or sotalol Receives: Drug: Antiarrhythmic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of death from cardiovascular causes.
- Cause of death will be established by evaluation of medical records by an endpoints adjudication committee. Cardiovascular death includes: sudden death, death due to worsening heart failure or death due to myocardial infarction
Measured: 2 years
Occurrence of appropriate shocks for VT/VF
Occurrence of appropriate shocks for VT/VF VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Measured: 2 years
Occurrence of hospitalization for heart failure
- Hospitalization for heart failure requiring overnight hospital stay and either increased oral diuretics or intravenous diuretics (at least 40 mg od frusemide or 10 mg od torasemide).
Measured: 2 years
Occurrence of severe complication of the ablation procedure.
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Measured: 2 years
Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Measured: 2 years
Secondary outcomes (5)
Number of patients with appropriate ICD therapies
Occurrence of appropriate ICD therapies is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope). Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Measured: 2 years
Number of patients with inappropriate ICD therapies
Occurrence of ICD therapies is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Appropriateness of ICD therapies is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Measured: 2 years
Number of patients with appropriate ICD shocks
Occurrence of ICD shocks is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Measured: 2 years
Number of patients with inappropriate ICD shocks
Occurrence of ICD shocks is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Appropriateness of ICD shocks is established by device-stored electrogram analysis performed by two expert independent electrophysiologists
Measured: 2 years
Quality of life measured with the The Short Form (36) Health Survey
Quality of life is measured with the The Short Form (36) Health Survey at pre-specified study follow-up visits (3,6,12,24 months).
The short-form (36) health survey consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
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 posted8 Nov 2018
- Study startJul 2010
- Primary completion29 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Monomorphic 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angel Arenal, MD, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734562
- Sponsor's protocol ID
- FIBHGM-0902
- Status last verified
- Nov 2018
- First submitted
- 13 Jun 2017
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Avila P, Berruezo A, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles F, Arenal A. Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial. Europace. 2023 Jul 4;25(7):euad181. doi: 10.1093/europace/euad181.
PubMed 37366571Arenal A, Avila P, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles FJ, Berruezo A. Substrate Ablation vs Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia. J Am Coll Cardiol. 2022 Apr 19;79(15):1441-1453. doi: 10.1016/j.jacc.2022.01.050.
PubMed 35422240
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase IV Multicentric Trial, Comparing the Efficacy and Safety of Radiofrequency Substrate Ablation of Monomorphic Ventricular Tachycardia vs. Antiarrhyhtmic Drugs in Patients Experiencing Appropriate ICD Shocks
- ClinicalTrials.gov ID
- NCT03734562
- Acronym / sponsor ID
- FIBHGM-0902
- Conditions
- Monomorphic Ventricular Tachycardia
- Keywords
- Ventricular tachycardia, Ischemic cardiomyopathy, Catheter Ablation, Antiarrhythmic drug therapy, ICD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 Nov 2018 (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.
To compare the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia.
Detailed description
Sustained monomorphic ventricular tachycardia remains an important source of morbidity and mortality in patients surviving a myocardial infarction. ICD´s have been proven to reduce mortality in this patients population, nonetheless, recurrent arrhythmia and ICD shocks are known to negatively impact ventricular function and are associated with worsening heart failure and mortality. We devised a controlled, randomized, parallel, single blind, phase IV clinical trial with the aim of comparing the efficacy and safety of substrate-based radiofrequency catheter ablation vs. antiarrhythmic drug therapy in patients with ischemic cardiomyopathy and scar-related sustained monomorphic ventricular tachycardia, implanted with an ICD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: AblationSubstrate-based radiofrequency catheter ablation |
| Antiarrhythmic drug therapy | Active comparator | Drug: Antiarrhythmic drugAntiarrhythmic drug therapy; amiodarone or sotalol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic cardiomyopathy, with ischemic myocardial scar
- Sustained monomorphic ventricular tachycardia
- Age > 18 years
- Prior ICD implantation
Key exclusion criteria (11 listed)
- VT storm
- NYHA functional class IV
- Additional indication for antiarrhythmic drug therapy
- Contraindication for both study drugs (amiodarone and sotalol).
- Uncontrolled myocardial ischemia.
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 |
|---|---|---|
| AblationAlso: Catheter AblationSubstrate-based radiofrequency catheter ablation | Procedure or surgery | Ablation |
| Antiarrhythmic drugAlso: Amiodarone, SotalolAmiodarone or sotalol therapy | Drug | Antiarrhythmic drug therapy |
Primary outcome
Occurrence of death from cardiovascular causes.
Time frame: 2 years
- Cause of death will be established by evaluation of medical records by an endpoints adjudication committee. Cardiovascular death includes: sudden death, death due to worsening heart failure or death due to myocardial infarction
Occurrence of appropriate shocks for VT/VF
Time frame: 2 years
Occurrence of appropriate shocks for VT/VF VT is measured by ICD interrogation, which is routinely done at the following follow-up visits: after the VT ablation procedure, or in case of suspected arrhythmic symptoms (palpitations, syncope or presyncope).
Occurrence of hospitalization for heart failure
Time frame: 2 years
- Hospitalization for heart failure requiring overnight hospital stay and either increased oral diuretics or intravenous diuretics (at least 40 mg od frusemide or 10 mg od torasemide).
Occurrence of severe complication of the ablation procedure.
Time frame: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
Time frame: 2 years
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
5 secondary outcomes
Number of patients with appropriate ICD therapies
Time frame: 2 years
Number of patients with inappropriate ICD therapies
Time frame: 2 years
Number of patients with appropriate ICD shocks
Time frame: 2 years
Number of patients with inappropriate ICD shocks
Time frame: 2 years
Quality of life measured with the The Short Form (36) Health Survey
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Derived from this study: PubMed 37366571Avila P, Berruezo A, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles F, Arenal A. Bayesian analysis of the Substrate Ablation vs. Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia trial. Europace. 2023 Jul 4;25(7):euad181. doi: 10.1093/europace/euad181.
- Derived from this study: PubMed 35422240Arenal A, Avila P, Jimenez-Candil J, Tercedor L, Calvo D, Arribas F, Fernandez-Portales J, Merino JL, Hernandez-Madrid A, Fernandez-Aviles FJ, Berruezo A. Substrate Ablation vs Antiarrhythmic Drug Therapy for Symptomatic Ventricular Tachycardia. J Am Coll Cardiol. 2022 Apr 19;79(15):1441-1453. doi: 10.1016/j.jacc.2022.01.050.
- Individual participant dataSharing planned: Undecided
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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.
Angel Arenal, MD, PhD principal investigator
Hospital General Universitario Gregorio Marañon
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 and Antiarrhythmic drug in people with Monomorphic Ventricular Tachycardia, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 11 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: finished, as of the sponsor's last update on 15 Mar 2019. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of death from cardiovascular causes. (time frame: 2 years). The study lists 5 primary outcomes in all. 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 NCT03734562, which also lists 2 linked publications.
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 15 Mar 2019.