Stereotactic Non-invasive Ablation of Ventricular Tachycardia

Not Applicable

Withdrawn

• Conditions: Ventricular Tachycardia
• Interventions: Procedure: 4-D navigated stereotactic radio surgical ablation

• Registration Number: NCT03819504
• Lead Sponsor: University Hospital Ostrava

Brief Summary

STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).

Detailed Description

The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-28
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with structural heart disease (ischemic and non-ischemic cardiomyopathy, previous surgery for congenital heart disease)
• Implanted ICD or CRT-D (cardiac resynchronization therapy defibrillator)
• Prior ≥1 catheter ablation procedure for monomorphic VT
• VT recurrence early (<12 months) after the last ablation with at least 2 episodes of recurrent VT, including 1 episode while on amiodarone (if not contraindicated)
• Age ≥30 years
• Signed an IRB-approved (Institutional Review Board) written informed consent

Exclusion Criteria

• Acute myocardial infarction or recent percutaneous coronary intervention (PCI) or cardiac surgery (<3 months)
• Primary electrical disease (channelopathy)
• Reversible cause of VT (e.g. drug-induced, intoxications, etc)
• Pregnancy or breastfeeding
• Chronic heart failure New York Heart Association (NYHA) Class IV
• Serious comorbidities with presumed life expectancy less than one year
• Significant peripheral artery disease precluding retrograde aortic mapping
• History of chest radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4-D navigated stereotactic radiosurgical ablation	4-D navigated stereotactic radio surgical ablation	Patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias will undergo 4-D navigated stereotactic radiosurgical ablation

Primary Outcome Measures

Name	Time	Method
3. Rate of acute (<3 months) and late radiation-induced events according to CTCAE 4.0.	53 months	The rate of acute (\<3 months) and late radiation-induced events according to CTCAE 4.0 will be observed.
Change of sustained VT burden in three 3-month intervals	50 months	Change of sustained VT burden in three 3-month intervals will be assessed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Composite endpoint of (i) all-cause death, (ii) appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or (iii) sustained VT below the detection threshold	50 months	All-cause death, appropriate ICD therapy (both shock and antitachycardia pacing) for VT/VF (ventricular fibrillation) or sustained VT below the detection threshold will be observed for up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.

Secondary Outcome Measures

Name	Time	Method
Composite endpoint of all-cause death and appropriate ICD shock	50 months	The composite endpoint of all-cause death and appropriate ICD shock will be observed for the period of up to 50 months. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Electric storm recurrence	53 months	The recurrence of electric storm will be observed. For all arrhythmic events, a 90-day post-radiosurgery blanking period will be applicable.
Change in quality of life	53 months	Change in quality of life will be observed using the standardised EQ-5D (5-dimension) questionnaire. EQ-5D is a standardised instrument in the form of a questionnaire developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The quality of life is assessed in five dimensions, with three levels in each dimension. The higher score the patient achieves, the better the quality of life.
Cardiovascular hospitalisations	53 months	The hospitalisations due to cardiovascular indications will be observed.

Trial Locations

Locations (3)

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Czech Republic, Czechia

Institute for Clinical and Experimental Medicine Prague; 🇨🇿 Prague, Central Bohemia, Czechia

Hospital Podlesí; 🇨🇿 Třinec, Moravian-Silesian Region, Czechia