Ignite Creation Date:
2024-05-06 @ 6:28 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05675865
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-12-14
Brief Title:
Cryoablation for Monomorphic Ventricular Tachycardia
Sponsor:
Adagio Medical
Organization:
Adagio Medical
Study Overview
Official Title:
Cryoablation for Monomorphic Ventricular Tachycardia IDE Study EFS and Pivotal
Status:
RECRUITING
Status Verified Date:
2024-05
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:
FULCRUM-VT
Brief Summary:
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia SMVT
Detailed Description:
A prospective single-arm multi-center open label pre-market clinical study designed to provide safety and efficacy data regarding the use of the Adagio System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients
Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation
Study subjects must have an Implantable Cardioverter Defibrillator ICD prior to the cryoablation procedure
This IDE study includes two phases an early feasibility EFS phase to support initial device safety and effectiveness and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application
Study subjects will include patients who experience recurrent SMVT and are scheduled for an endocardial VT ablation
Study subjects must have an Implantable Cardioverter Defibrillator ICD prior to the cryoablation procedure
This IDE study includes two phases an early feasibility EFS phase to support initial device safety and effectiveness and a Pivotal Study phase to collect safety and effectiveness data for a future PMA marketing application
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None