Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06455020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This is a multi-center parallel-group randomized open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia VT
Detailed Description:
The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor with a high 30-day mortality rate 30 resulting in extremely heavy medical burden Current guidelines lack specific recommendations for managing this condition The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs sedation and anesthesia followed by haemodynamic mechanical support devices Catheter ablation is only used as the final rescue treatment Typically patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs facing increased risks of complications from enhanced haemodynamic support Studies have shown that these patients often eventually progress to irreversible pump failure miss the window for effective catheter ablation and ultimately die Early cardioversion and maintenance of sinus rhythm may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT Therefore emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia
In this study we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia Current study will include 96 patients and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 11 fashion The follow-up duration is 1 year The primary outcome is a composite outcome of VT recurrence cardiovascular re-hospitalization and all-cause mortality
In this study we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia Current study will include 96 patients and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 11 fashion The follow-up duration is 1 year The primary outcome is a composite outcome of VT recurrence cardiovascular re-hospitalization and all-cause mortality
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