STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Procedure: Repeated catheter ablation; Procedure: Radiosurgery

• Registration Number: NCT04612140
• Lead Sponsor: University Hospital Ostrava

Brief Summary

A multicentre trial on clinical effects of radiosurgical ablation of ventricular tachycardia (VT).

Detailed Description

Patients with previously failed conventional RF catheter ablation will be randomized to radiosurgery (active treatment group) or repeated catheter ablation (control treatment group). Details on inclusion and exclusion criteria are provided below.

Randomization Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of structural heart disease (SHD), left ventricular (LV) ejection fraction, and serum B-type natriuretic peptide (NT-proBNP) level.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients with structural heart disease (SHD) of any etiology (ischemic, non-ischemic, congenital corrected or uncorrected)

2. Implanted implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)

3. Prior ≥1 catheter ablation procedure for VT due to SHD of them the last one performed in the expert center and employed:

   3.1 all meaningful mapping/ablation approaches (endocardial/epicardial access to left / right ventricular substrate as possible or appropriate) 3.2 precise electroanatomical mapping of the arrhythmogenic substrate in anticipation of future radiosurgery 3.3 additional mapping of structures used for precise image integration (aortic arch, left main ostium, right ventricular endocardial surface)

4. VT recurrence after the last catheter ablation fulfilling all criteria as follows:

   4.1 clinically relevant and requiring further intervention 4.2 compatible with the previously characterized arrhythmogenic substrate 4.3 occurred on stable antiarrhythmic medication (mostly amiodarone) unless contraindicated 4.4 reversible cause excluded

5. Signed an Institutional Review Board (IRB)-approved written informed consent

Exclusion Criteria

1. Age < 20 years
2. Acute coronary syndrome or recent percutaneous coronary intervention or cardiac surgery (< 3 months)
3. Primary electrical disease (channelopathy)
4. Pregnancy or breastfeeding
5. Chronic heart failure with New York Heart Association (NYHA) Class IV
6. Serious comorbidities with presumed life expectancy less than one year
7. Significant peripheral artery disease precluding retrograde aortic mapping

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repeated catheter ablation	Repeated catheter ablation	Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.
Radiosurgery	Radiosurgery	Eligible patients will be assigned to 2 treatment arms - radiosurgery (active arm) or repeated catheter ablation (control arm) in 1:1 fashion by covariate-adaptive randomization algorithm considering age, gender, etiology of SHD, LV ejection fraction, and serum NT-proBNP level.

Primary Outcome Measures

Name	Time	Method
Recurrence of sustained VT after 3-month blanking period	3 months	Recurrence of sustained VT after 3-month blanking period will be assessed.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular hospitalization	24 months	The number of hospitalisations due to cardiovascular indications will be observed.
Non-inducibility of VT at 6 months	6 months	TRUE/FALSE - Pacing protocol will be using 2 basic cycle length drives (600 and 400 ms) and 1-3 extrastimuli with coupling intervals decremented by 10 ms up to the refractoriness or 200 ms.
Electric storm recurrence	24 months	The recurrence of electric storm will be observed.
Rate of major procedure-related complications (control arm)	24 months	The rate of major procedure-related complications will be observed among the study subjects enrolled to the control arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Change in echocardiographic indices	24 months	Left vetricle ejection fraction (%) will be observed.
Rate of late radiation-induced events	24 months	The rate of late radiation-induced events will be assessed according to CTCAE 5.0 in each cohort of isodose line level, specifically, rate of radiation myocarditis, pericarditis, and pneumonitis.
VT burden according to implantable device	3 months	Number of sustained VT burden in three 3-month intervals after radiosurgery will be assessed.
Recurrence of sustained VT excluding antitachycardia-pacing (ATP)-treated episodes	24 months	Recurrence of sustained VT excluding ATP-treated episodes will be assessed.
Dynamics of serum troponin level	24 months	The dynamics of serum troponin level will be observed in all study subjects.
All-cause death	24 months	The all-cause death will be observed.
Extent of scar	6 months	The extent of scar will be assessed 6 months after radiosurgery, based on invasive electroanatomical mapping.
Change in quality of life: EQ-5D	24 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.
Rate of acute post-radiation complications (intervention arm)	24 months	The rate of acute post-radiation complications will be observed among the study subjects enrolled to the intervention arm of the study, according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Radiation dose	24 months	The radiation dose will be observed for each interventional procedure, CT imaging and radiosurgery, together with the cumulative dose.
Need of antiemetic drugs	24 months	The need of antiemetic drugs will be assessed in all study subjects.

Trial Locations

Locations (2)

Institute for Clinical and Experimental Medicine; 🇨🇿 Praha, Czechia

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