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

Monomorphic Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734562
• Other study ID #: FIBHGM-0902
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: September 30, 2017

Study information

• Verified date: November 2018
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 30, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monomorphic Ventricular Tachycardia
• Tachycardia
• Tachycardia, Ventricular

Intervention

Procedure:
• Ablation
Substrate-based radiofrequency catheter ablation

Drug:
• Antiarrhythmic drug
Amiodarone or sotalol therapy

Locations

Country	Name	City	State
Spain	Hospital General UNiversitario Gregorio Marañon	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years
Secondary	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	2 years