This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.
University Hospital of Split
Split, Croatia
Characterization of Insertion Procedure - Implantation: Insertion Success
Insertion Success. (Yes/No); Place Device into Pocket (Yes/No);
Time frame: up to 24 weeks
Characterization of Insertion Procedure - Implantation: Incision Size
Incision Size in millimeters (mm).
Time frame: up to 24 weeks
Characterization of Insertion Procedure - Implantation: Device Orientation
Device Orientation: Location between the suprasternal notch and the left nipple, (position A); or left parasternal region (position B) or left sub-mammary position can be used (position C).
Time frame: up to 24 weeks
Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.
Duration of Insertion Procedure in minutes (min).
Time frame: up to 24 weeks
Characterization of Explant Procedure - Device removal: Removal Success
Removal Success (Yes/No)
Time frame: up to 24 weeks
Characterization of Explant Procedure - Device removal: Incision Size
Incision Size in millimeters (mm)
Time frame: up to 24 weeks
Characterization of Explant Procedure - Device removal: Duration of explant procedure
Duration of explant procedure in minutes (min).
Time frame: up to 24 weeks
Device and Procedural Safety over a period of 180 days
1. Number of Serious Adverse Events (SAE) related to the Device or insertion procedure. 2. Number of Participants with Device-related or Procedure-related Serious Adverse Event that require additional invasive intervention (including need to for device removal, device replacement, surgical repositioning of the device, or another surgery related to the device or primary insertion procedure).
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Time frame: up to 24 weeks
Success of Wireless Transmissions over a period of 180 days
Assess the percentage of successful wireless transmissions from the system throughout the study duration (transmission successful, the transmission failed or transmission re-try).
Time frame: up to 24 weeks
Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.
ECG signal Assessment.
Time frame: up to 24 weeks
Comparison of the Future Cardia™ ECG tracing and detection of arrhythmias with 7-day ECG recorder tracings or 24-hr Holter recording (optional, when available).
Comparison of the Future Cardia™ ECG tracing and detection of arrhythmias with 7-day ECG recorder tracings or 24-hr Holter recording.
Time frame: up to 24 weeks
Usability: survey of the implanting physicians regarding the ease of implantation and use of the system for monitoring during follow-up.
Usability Survey
Time frame: up to 24 weeks
Number of Serious Adverse Events (SAE) related to the Device or study procedure in patients who elect to continue monitoring using the ICM device after the 6-month study follow-up.
Long-term safety in Post study follow-up (\> 6 months up to 2 years).
Time frame: 2 Years