STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease

Status: Completed
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

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

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

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

⁃ 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)

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

⁃ 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

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

Time Frame
Start Date: 2020-10-01
Completion Date: 2024-06-30
Participants
Target number of participants: 22
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Collaborators: Institute for Clinical and Experimental Medicine, Hospital Podlesi
Leads: University Hospital Ostrava

This content was sourced from clinicaltrials.gov