TY - JOUR
T1 - Radiosurgery for ventricular tachycardia (RAVENTA)
T2 - interim analysis of a multicenter multiplatform feasibility trial
AU - Krug, David
AU - Zaman, Adrian
AU - Eidinger, Lina
AU - Grehn, Melanie
AU - Boda-Heggemann, Judit
AU - Rudic, Boris
AU - Mehrhof, Felix
AU - Boldt, Leif Hendrik
AU - Hohmann, Stephan
AU - Merten, Roland
AU - Buergy, Daniel
AU - Fleckenstein, Jens
AU - Kluge, Anne
AU - Rogge, Annette
AU - Both, Marcus
AU - Rades, Dirk
AU - Tilz, Roland Richard
AU - Olbrich, Denise
AU - König, Inke R.
AU - Siebert, Frank Andre
AU - Schweikard, Achim
AU - Vonthein, Reinhard
AU - Bonnemeier, Hendrik
AU - Dunst, Jürgen
AU - Blanck, Oliver
N1 - Publisher Copyright:
© 2023, The Author(s).
PY - 2023/7
Y1 - 2023/7
N2 - Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.
AB - Background: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. Methods: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. Results: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. Conclusion: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. Trial registration number: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.
UR - http://www.scopus.com/inward/record.url?scp=85161345678&partnerID=8YFLogxK
U2 - 10.1007/s00066-023-02091-9
DO - 10.1007/s00066-023-02091-9
M3 - Journal articles
C2 - 37285038
AN - SCOPUS:85161345678
SN - 0179-7158
VL - 199
SP - 621
EP - 630
JO - Strahlentherapie und Onkologie
JF - Strahlentherapie und Onkologie
IS - 7
ER -
