Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592001
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead ASCEND EV Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead ASCEND EV Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCEND EV
Brief Summary:
The ASCEND EV Study is a prospective multi-center single-arm non-randomized study without concurrent or historical controls The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation
The objectives of the study are to 1 preliminarily validate safety and effectiveness of the Atala lead as a permanent ICD lead when used with a compatible ICD pulse generator 2 evaluate suitability of clinical study testing methods and 3 inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation
The objectives of the study are to 1 preliminarily validate safety and effectiveness of the Atala lead as a permanent ICD lead when used with a compatible ICD pulse generator 2 evaluate suitability of clinical study testing methods and 3 inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation
Detailed Description:
The primary safety endpoint is freedom from major Adverse Device Effects ADEs through 3-months The primary performance endpoint is successful induced ventricular arrhythmia IVA test in the final system configuration
Up to three 3 Investigational Sites will participate with up to 35 Subjects enrolled in the study Subjects who meet current indications for ICD therapy will be eligible for participation Eligible Subjects will receive an Atala lead connected to a commercially available ICD positioned in a left pectoral or left lateral location
The Atala lead will be connected to a compatible ICD pulse generator and tested to verify appropriate sensing and defibrillation Abbreviated IVA testing will be performed at the 3-month follow-up visit to verify continued sensing and defibrillation effectiveness Starting at 6 months Subjects will be followed every 6 months until the study is closed The study is expected to remain open for at least 3 years
Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 3-month visit
Up to three 3 Investigational Sites will participate with up to 35 Subjects enrolled in the study Subjects who meet current indications for ICD therapy will be eligible for participation Eligible Subjects will receive an Atala lead connected to a commercially available ICD positioned in a left pectoral or left lateral location
The Atala lead will be connected to a compatible ICD pulse generator and tested to verify appropriate sensing and defibrillation Abbreviated IVA testing will be performed at the 3-month follow-up visit to verify continued sensing and defibrillation effectiveness Starting at 6 months Subjects will be followed every 6 months until the study is closed The study is expected to remain open for at least 3 years
Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 3-month visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None