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

NCT03734562 | Completed DMC

• 1 other identifier: FIBHGM-0902
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Monomorphic Ventricular Tachycardia

Keywords

Ventricular tachycardia; Ischemic cardiomyopathy; Catheter Ablation; Antiarrhythmic drug therapy; ICD

Outcome Measures

Primary Outcomes (5)

• 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

  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).

  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).

  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

  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

  2 years

Secondary Outcomes (5)

• Number of patients with appropriate ICD therapies

  2 years

• Number of patients with inappropriate ICD therapies

  2 years

• Number of patients with appropriate ICD shocks

  2 years

• Number of patients with inappropriate ICD shocks

  2 years

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

  2 years

Study Arms (2)

Ablation

EXPERIMENTAL

Substrate-based radiofrequency catheter ablation

Procedure: Ablation

Antiarrhythmic drug therapy

ACTIVE COMPARATOR

Antiarrhythmic drug therapy; amiodarone or sotalol

Drug: Antiarrhythmic drug

Interventions

Ablation PROCEDURE

Substrate-based radiofrequency catheter ablation

Also known as: Catheter Ablation

Ablation

Antiarrhythmic drug DRUG

Amiodarone or sotalol therapy

Also known as: Amiodarone, Sotalol

Antiarrhythmic drug therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General UNiversitario Gregorio Marañon

Madrid, 28009, Spain

Location

Related Publications (2)

• 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.

  PMID: 37366571 DERIVED

• 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.

  PMID: 35422240 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation; Anti-Arrhythmia Agents; Amiodarone; Sotalol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Angel Arenal, MD, PhD

  Hospital General Universitario Gregorio Marañon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: ICD therapy analysis and outcome adjudication is performed by physicians blinded to the study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: November 8, 2018
• Study Start: July 1, 2010
• Primary Completion: September 29, 2017
• Study Completion: September 30, 2017
• Last Updated: March 15, 2019

Record last verified: 2018-11

Locations

ES (1)