NCT03867747

Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment. Secondary endpoints: evaluated at 1 year * Changes in ventricular tachycardia episodes and ICD shocks * Changes in antiarrhythmic medication due to treatment effects * Occurrence of possibly treatment related adverse events in the first year after treatment * Changes in patient-reported quality of life * Overall survival * Safety profile

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
RADIATION	Cardiac Radiosurgery	Image-guided stereotactic body radiation therapy

Timeline

• Start date: 2019-12-02
• Primary completion: 2023-11-20
• Completion: 2024-10-20
• First posted: 2019-03-08
• Last updated: 2025-01-08

Locations

6 sites across 1 country: Germany