Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)

Status: Completed
Location: See all (6) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 Gy. Investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with structural heart disease and implantable cardioverter defibrillator (ICD)

• Age \> 18 years

• either

‣ Recurring symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes within the 3 months prior to inclusion or

⁃ induction of symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by ICD or during electrophysiology studies (EPS) or both, a) and b)

• Refractory to antiarrhythmic combination therapy

• Beside the cardiac conditions: No competing illness that would additionally limit the life expectancy to less than 6 months

• No prior radiation therapy in the thorax area

• No pregnancy and no active breastfeeding

• Ability to consent and consent to study participation

Locations
Other Locations
Germany
University Medical Center Charite Berlin
Berlin
Medizinische Hochschule Hannover
Hanover
University Medical Center Schleswig-Holstein
Kiel
University Medical Center Schleswig-Holstein
Lübeck
University Clinic Mannheim
Mannheim
Hospital of the Ludwig-Maximilians-University Munich
Munich
Time Frame
Start Date: 2019-12-02
Completion Date: 2024-10-20
Participants
Target number of participants: 20
Treatments
Experimental: Cardiac Radiosurgery
25 Gy in a single fraction
Sponsors
Leads: University Hospital Schleswig-Holstein
Collaborators: Universitätsmedizin Mannheim

This content was sourced from clinicaltrials.gov