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

NCT06167434 | Active Not Recruiting FDA Device

• 1 other identifier: FC-2022-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Telemedicine; Cardiac Arrhythmia; ECG; PCG; Accelerometer; Cardiac monitor; Insertable cardiac monitor

Outcome Measures

Primary Outcomes (9)

• Characterization of Insertion Procedure - Implantation: Insertion Success

  Insertion Success. (Yes/No); Place Device into Pocket (Yes/No);

  up to 24 weeks

• Characterization of Insertion Procedure - Implantation: Incision Size

  Incision Size in millimeters (mm).

  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).

  up to 24 weeks

• Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.

  Duration of Insertion Procedure in minutes (min).

  up to 24 weeks

• Characterization of Explant Procedure - Device removal: Removal Success

  Removal Success (Yes/No)

  up to 24 weeks

• Characterization of Explant Procedure - Device removal: Incision Size

  Incision Size in millimeters (mm)

  up to 24 weeks

• Characterization of Explant Procedure - Device removal: Duration of explant procedure

  Duration of explant procedure in minutes (min).

  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).

  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).

  up to 24 weeks

Secondary Outcomes (4)

• Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.

  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).

  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.

  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.

  2 Years

Study Arms (1)

Single Arm

EXPERIMENTAL

Insertable Cardiac Monitor Implant.

Device: Future Cardia™ Insertable Cardiac Monitoring (ICM) System

Interventions

Future Cardia™ Insertable Cardiac Monitoring (ICM) System DEVICE

The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old and \<75 years old)
• 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:
• paroxysmal AF patients that are candidates for AF ablation;
• patients hospitalized for symptomatic AF, who failed to convert in the emergency room (ER):
• outpatients who require treatment with anti-arrhythmic drugs (AAD) (mostly propafenone or flecainide; more rarely sotalol or amiodaron are given for PAF).
• Patient is willing and able to provide written informed consent.
• Patient is willing and able to comply with the protocol, including follow-up visits and data transmissions.

You may not qualify if:

• Patient who is scheduled to have MRI or is likely to require MR screening. The Future Cardia implant is not compatible with MRI.
• 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.
• Compromised immune system or at high risk of developing an infection.
• Active systemic infection or history of any infection within the last 30 days.
• Subjects who are female must:
• have a negative pregnancy test by β-hCG blood test.
• not breastfeeding
• 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.
• Subject is currently enrolled in another investigational study.
• 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.
• 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).
• Obesity, Class 2 (BMI ≥ 35-40) or Class 3 (BMI ≥ 40).
• Subject is unwilling or unable to comply with the study procedures.
• Subject is legally incapacitated and unable to provide written informed consent.
• Patient with abnormal thoracic anatomy or scar tissue at the implant site that may adversely impact the insertion procedure.

Sponsors & Collaborators

• Future Cardia, Inc: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (1)

University Hospital of Split

Split, Croatia

Location

Related Links

• Future Cardia Inc.Website
• Meditrial Europe Ltd.CRO

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Bradycardia; Tachycardia, Ventricular; Heart Arrest

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Ante Anic, MD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)