Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
NCT06167434 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-08-08
Summary
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
Conditions
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Bradycardia
- Ventricular Tachycardia
- Asystole
Interventions
- DEVICE
-
Future Cardia™ Insertable Cardiac Monitoring (ICM) System
The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.
Sponsors & Collaborators
-
Meditrial Europe Ltd.
collaborator INDUSTRY -
Future Cardia, Inc
lead INDUSTRY
Principal Investigators
-
Ante Anic, MD · University Hospital Split
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-12-01
- FDA Device
- Yes
Countries
- Croatia
Study Locations
More Related Trials
-
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
NCT01486316 ·Status: COMPLETED ·Phase: NA
-
Minimizing Ventricular Pacing
NCT01611389 ·Status: UNKNOWN ·Phase: NA
-
Extravascular ICD Pivotal Study
NCT04060680 ·Status: COMPLETED ·Phase: NA
-
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
NCT06474819 ·Status: RECRUITING ·Phase: NA
-
BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
NCT06840509 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Identification of the Pericardiophrenic Vein During Cardiac Device Implant Procedures to Prevent Extracardiac Stimulation
NCT01008670 ·Status: COMPLETED
-
Home-Monitoring in Implantable Cardioverter Defibrillator (ICD) Patients
NCT00787683 ·Status: UNKNOWN ·Phase: NA
-
A Novel Healthcare Information Technology Tool to Improve Care in Patients With Atrial Fibrillation
NCT02623517 ·Status: COMPLETED
-
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
NCT02772380 ·Status: COMPLETED ·Phase: NA
-
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
NCT00345592 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical and Device Functional Assessment of Real World ICD Patients
NCT02341768 ·Status: COMPLETED
-
Remote ECG Monitoring of TAVI Patients
NCT03810820 ·Status: UNKNOWN ·Phase: NA
-
Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF
NCT06384963 ·Status: RECRUITING ·Phase: NA
-
CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients
NCT00531661 ·Status: COMPLETED ·Phase: NA
-
Micra Transcatheter Pacing Study
NCT02004873 ·Status: COMPLETED ·Phase: NA
-
The REACT-ICD Trial
NCT02439424 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device
NCT00957541 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Determine the Feasibility of Wireless Electrocardiography
NCT02162394 ·Status: COMPLETED
-
VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients
NCT02113033 ·Status: COMPLETED ·Phase: PHASE2
-
Measurement of Left and Right Atria From CT Scans of Cardiac Rhythm Disorder Cases
NCT01165593 ·Status: COMPLETED
-
Implantable Cardioverter Defibrillators - Improving Risk Stratification
NCT01944514 ·Status: COMPLETED
-
Comparative Analysis in Detection of Atrial Arrhythmia and ECG Quality in Three Different Insertable Cardiac Monitors
NCT04471584 ·Status: UNKNOWN ·Phase: NA
-
Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
NCT03657134 ·Status: COMPLETED ·Phase: NA
-
EDEN Intracardiac Electrogram Recording and Classifying System
NCT07137455 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block (BLOCK HF)
NCT00267098 ·Status: COMPLETED ·Phase: NA