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

Primary Purpose

Monomorphic Ventricular Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ablation
Antiarrhythmic drug
Sponsored by
Hospital General Universitario Gregorio Marañon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Monomorphic Ventricular Tachycardia focused on measuring Ventricular tachycardia, Ischemic cardiomyopathy, Catheter Ablation, Antiarrhythmic drug therapy, ICD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General UNiversitario Gregorio Marañon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ablation

Antiarrhythmic drug therapy

Arm Description

Substrate-based radiofrequency catheter ablation

Antiarrhythmic drug therapy; amiodarone or sotalol

Outcomes

Primary Outcome Measures

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
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).
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).
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
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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
June 13, 2017
Last Updated
March 14, 2019
Sponsor
Hospital General Universitario Gregorio Marañon
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1. Study Identification

Unique Protocol Identification Number
NCT03734562
Brief Title
Trial to Evaluate the Efficacy and Safety of Substrate Ablation of Monomorphic Ventricular Tachycardia
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 29, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Universitario Gregorio Marañon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monomorphic Ventricular Tachycardia
Keywords
Ventricular tachycardia, Ischemic cardiomyopathy, Catheter Ablation, Antiarrhythmic drug therapy, ICD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
ICD therapy analysis and outcome adjudication is performed by physicians blinded to the study group.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Experimental
Arm Description
Substrate-based radiofrequency catheter ablation
Arm Title
Antiarrhythmic drug therapy
Arm Type
Active Comparator
Arm Description
Antiarrhythmic drug therapy; amiodarone or sotalol
Intervention Type
Procedure
Intervention Name(s)
Ablation
Other Intervention Name(s)
Catheter Ablation
Intervention Description
Substrate-based radiofrequency catheter ablation
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Other Intervention Name(s)
Amiodarone, Sotalol
Intervention Description
Amiodarone or sotalol therapy
Primary Outcome Measure Information:
Title
Occurrence of death from cardiovascular causes.
Description
- 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
Time Frame
2 years
Title
Occurrence of appropriate shocks for VT/VF
Description
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).
Time Frame
2 years
Title
Occurrence of hospitalization for heart failure
Description
- 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).
Time Frame
2 years
Title
Occurrence of severe complication of the ablation procedure.
Description
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Time Frame
2 years
Title
Occurrence of interruption of antiarrhythmic drug therapy due to severe side effects
Description
Occurrence of severe complications of the ablation procedure Will be identified through review of patient clinical reports
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of patients with appropriate ICD therapies
Description
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
Time Frame
2 years
Title
Number of patients with inappropriate ICD therapies
Description
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
Time Frame
2 years
Title
Number of patients with appropriate ICD shocks
Description
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
Time Frame
2 years
Title
Number of patients with inappropriate ICD shocks
Description
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
Time Frame
2 years
Title
Quality of life measured with the The Short Form (36) Health Survey
Description
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
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angel Arenal, MD, PhD
Organizational Affiliation
Hospital General Universitario Gregorio Marañon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General UNiversitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35422240
Citation
Arenal 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.
Results Reference
derived

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

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