NCT06167434

Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Future Cardia, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Bradycardia
• Ventricular Tachycardia
• Asystole

Interventions

Type	Name	Description
DEVICE	Future Cardia™ Insertable Cardiac Monitoring (ICM) System	The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-12-12
• Last updated: 2025-08-08

Locations

1 site across 1 country: Croatia

Regulatory

• FDA-regulated device study