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Completed

NCT Number: NCT03734562

Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia

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.

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Key information

Conditions

Monomorphic Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General UNiversitario Gregorio Marañon

Madrid, 28009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic cardiomyopathy, with ischemic myocardial scar
  • Sustained monomorphic ventricular tachycardia
  • Age > 18 years
  • Prior ICD implantation

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Ablation

Procedure

Substrate-based radiofrequency catheter ablation

Other names: Catheter Ablation

Antiarrhythmic drug

Drug

Amiodarone or sotalol therapy

Other names: Amiodarone, Sotalol

Primary outcomes

  1. 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

  2. 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).

  3. 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).

  4. 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

  5. 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

Secondary outcomes

  1. Number of patients with appropriate ICD therapies

    Time frame: 2 years

    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

  2. Number of patients with inappropriate ICD therapies

    Time frame: 2 years

    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

  3. Number of patients with appropriate ICD shocks

    Time frame: 2 years

    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

  4. Number of patients with inappropriate ICD shocks

    Time frame: 2 years

    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

  5. Quality of life measured with the The Short Form (36) Health Survey

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Gregorio Marañon

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2018
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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