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

Not Applicable

Recruiting

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation; Bradycardia; Asystole; Ventricular Tachycardia
• Interventions: Device: Future Cardia™ Insertable Cardiac Monitoring (ICM) System

• Registration Number: NCT06167434
• Lead Sponsor: Future Cardia, Inc

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 Timeline

• Study First Submitted: 2023-11-21
• Study Start: 2023-12-01
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Adult patients (≥18 years old and <75 years old)

2. Paroxysmal AF, defined as AF that terminates spontaneously or with intervention within 7 days of onset (ESC 2020 guidelines). In order to be included, patients must present one of the following conditions:

   1. paroxysmal AF patients that are candidates for AF ablation;
   2. patients hospitalized for symptomatic AF, who failed to convert in the emergency room (ER):
   3. outpatients who require treatment with anti-arrhythmic drugs (AAD) (mostly propafenone or flecainide; more rarely sotalol or amiodaron are given for PAF).

3. Patient is willing and able to provide written informed consent.

4. Patient is willing and able to comply with the protocol, including follow-up visits and data transmissions.

Exclusion Criteria

1. Patient who is scheduled to have MRI or is likely to require MR screening. The Future Cardia implant is not compatible with MRI.

2. Currently indicated for or implanted with a cardiovascular implantable electronic device (CIED) (e.g., ICM or ILR, pacemaker, ICD, CRT-D or CRT-P device) or hemodynamic monitoring system.

3. Compromised immune system or at high risk of developing an infection.

4. Active systemic infection or history of any infection within the last 30 days.

5. Subjects who are female must:

   1. have a negative pregnancy test by β-hCG blood test.
   2. not breastfeeding
   3. either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or if they have childbearing potential, agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.

6. Subject is currently enrolled in another investigational study.

7. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.

8. Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis).

9. Obesity, Class 2 (BMI ≥ 35-40) or Class 3 (BMI ≥ 40).

10. Subject is unwilling or unable to comply with the study procedures.

11. Subject is legally incapacitated and unable to provide written informed consent.

    Exclusion criteria for the study procedure:

12. Patient with abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure.

13. For patients currently taking warfarin at the time of insertion, most recent INR value (within 7 days) is less than 3.5 for an acceptable risk of bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Future Cardia™ Insertable Cardiac Monitoring (ICM) System	Insertable Cardiac Monitor Implant.

Primary Outcome Measures

Name	Time	Method
Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.	Day 0	Duration of Insertion Procedure in minutes (min).
Characterization of Explant Procedure - Device removal: Incision Size	Up to 6 months	Incision Size in millimeters (mm)
Characterization of Insertion Procedure - Implantation: Device Orientation	Day 0	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).
Characterization of Insertion Procedure - Implantation: Insertion Success	Day 0	Insertion Success. (Yes/No)
Characterization of Insertion Procedure - Implantation: Incision Size	Day 0	Incision Size in millimeters (mm).
Characterization of Explant Procedure - Device removal: Removal Success	up to 6 months	Removal Success (Yes/No)
Characterization of Explant Procedure - Device removal: Duration of explant procedure	Up to 6 months	Duration of explant procedure in minutes (min).
Device and Procedural Safety over a period of 180 days	6 months	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).
Success of Wireless Transmissions over a period of 180 days	6 months	Assess the percentage of successful wireless transmissions from the system throughout the study duration (transmission successful, the transmission failed or transmission re-try).

Secondary Outcome Measures

Name	Time	Method
Usability: survey of the implanting physicians regarding the ease of implantation and use of the system for monitoring during follow-up.	6 months	Usability Survey
Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.	6 months	ECG signal Assessment.
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).	6 months	Comparison of the Future Cardia™ ECG tracing and detection of arrhythmias with 7-day ECG recorder tracings or 24-hr Holter recording.
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.	2 Years	Long-term safety in Post study follow-up (\> 6 months up to 2 years).

Trial Locations

Locations (1)

University Hospital of Split; 🇭🇷 Split, Croatia