Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03819504
Status:
WITHDRAWN
Last Update Posted:
2020-10-19
First Post:
2019-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Non-invasive Ablation of Ventricular Tachycardia
Sponsor:
University Hospital Ostrava
Organization:
Study Overview
Official Title:
STereotactic Ablative Radiosurgery of Recurrent Ventricular Tachycardia in Structural Heart Disease
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in the design of the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
STereotactic Ablative Radiosurgery of recurrent Ventricular Tachycardia in structural heart disease (STAR-VT).
Detailed Description:
The goal of this project is to evaluate feasibility and safety/toxicity of elimination of ventricular tachycardia (VT) associated with structural heart disease by noninvasive strategy, stereotactic radiosurgical ablation in an indication of bail-out procedure after failed catheter ablation. The arrhythmogenic substrate will be identified by imaging techniques and functionally by electroanatomic mapping and pacing. The recipients of stereotactic surgery will be patients after 2 unsuccessful catheter ablations for monomorphic VTs (one of the procedures will be performed in an expert center). The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be a critical region of the substrate defined by a combination of imaging and functional methods with an export of the merged image-electroanatomical map into the radiosurgery planning console. Primary endpoints will be a reduction of the burden of sustained VT, time to death or arrhythmic storm or appropriate therapy with implantable cardioverter-defibrillator (ICD) for isolated VT and/or time do development of radiation toxicity (both acute and late).
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NV19-02-00212 | OTHER_GRANT | Ministry of Health of the Czech Republic | View |