Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360939
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-01-02
Brief Title:
Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
Sponsor:
Western Sydney Local Health District
Organization:
Western Sydney Local Health District
Study Overview
Official Title:
Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Radioablate
Brief Summary:
The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy SBRT in treating ventricular tachycardia VT in patients with advanced structural heart disease The main questions it aims to answer are
What is the efficacy of SBRT compared to catheter ablation CA in achieving a 75 reduction in VT burden at 6 months
What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA standard of care
What is the efficacy of SBRT compared to catheter ablation CA in achieving a 75 reduction in VT burden at 6 months
What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA standard of care
Detailed Description:
Hypothesis
We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia VT that stereotactic body radiation therapy SBRT will be superior in reducing VT burden compared to standard care comprising of catheter ablation CA and routine medical care with acceptable safety and adverse events
Aims
This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in
1 An improvement in a primary outcome of proportion of patients with a 75 reduction in VT burden in the 6 months following intervention compared to the 6 months intervention
2 Comparable safety profile serious adverse events SAE and adverse events of special interest AESI at 6 months
3 reduction in secondary endpoints at 6 12 24 and 36 months of any VT recurrence absolute reduction in VT burden compared to 6 months pre-treatment number of anti-arrhythmic drugs AADs compared to pre-treatment cardiovascular hospitalisation all-cause mortality cardiac transplantation combined endpoint of cardiovascular hospitalisationtransplantmortality SAE and AESI from treatment ventricular function abd change of quality of life QOL metrics at 12 months
We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia VT that stereotactic body radiation therapy SBRT will be superior in reducing VT burden compared to standard care comprising of catheter ablation CA and routine medical care with acceptable safety and adverse events
Aims
This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in
1 An improvement in a primary outcome of proportion of patients with a 75 reduction in VT burden in the 6 months following intervention compared to the 6 months intervention
2 Comparable safety profile serious adverse events SAE and adverse events of special interest AESI at 6 months
3 reduction in secondary endpoints at 6 12 24 and 36 months of any VT recurrence absolute reduction in VT burden compared to 6 months pre-treatment number of anti-arrhythmic drugs AADs compared to pre-treatment cardiovascular hospitalisation all-cause mortality cardiac transplantation combined endpoint of cardiovascular hospitalisationtransplantmortality SAE and AESI from treatment ventricular function abd change of quality of life QOL metrics at 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None