Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-29 @ 4:16 AM
Study NCT ID:
NCT06167434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Sponsor:
Future Cardia, Inc
Organization:
Study Overview
Official Title:
Clinical Investigation of the Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation Voice Of the Heart Trial (First-in-Human Study)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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 study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
Detailed Description:
The objective of this first-in-human, prospective, multi-center, pre-market single-arm clinical investigation is to evaluate the safety and performance of the Future Cardia™ ICM by assessing the insertion procedure, sensing and detection performance and data monitoring transmission success, and device- or procedure-related complication rates over a 6-month follow-up period.
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?:
True
Is an FDA AA801 Violation?: