Arrhythmias, CardiacNCT06167434
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
A study testing Future Cardia™ Insertable Cardiac Monitoring (ICM) System in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Future Cardia, Inc at 1 site in Croatia.
Trial summary
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation, Bradycardia
- What is being tested?
- Future Cardia™ Insertable Cardiac Monitoring (ICM) System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of the Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation Voice Of the Heart Trial (First-in-Human Study)
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
Read the 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.
- Being tested
- Future Cardia™ Insertable Cardiac Monitoring (ICM) System
- Keywords
- Telemedicine, Cardiac Arrhythmia, ECG, PCG, Accelerometer, Cardiac monitor, Insertable cardiac monitor
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Bradycardia, Tachycardia, Ventricular, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Future Cardia™ Insertable Cardiac Monitoring (ICM) SystemDevice
The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Insertable Cardiac Monitor Implant. Receives: Device: Future Cardia™ Insertable Cardiac Monitoring (ICM) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Insertion Procedure - Implantation: Insertion Success
Insertion Success. (Yes/No); Place Device into Pocket (Yes/No);
Measured: up to 24 weeks
Characterization of Insertion Procedure - Implantation: Incision Size
Incision Size in millimeters (mm).
Measured: 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).
Measured: up to 24 weeks
Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.
Duration of Insertion Procedure in minutes (min).
Measured: up to 24 weeks
Characterization of Explant Procedure - Device removal: Removal Success
Removal Success (Yes/No)
Measured: up to 24 weeks
Characterization of Explant Procedure - Device removal: Incision Size
Incision Size in millimeters (mm)
Measured: up to 24 weeks
Characterization of Explant Procedure - Device removal: Duration of explant procedure
Duration of explant procedure in minutes (min).
Measured: up to 24 weeks
Device and Procedural Safety over a period of 180 days
- Number of Serious Adverse Events (SAE) related to the Device or insertion procedure.
- 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).
Measured: 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).
Measured: 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.
ECG signal Assessment.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Cardia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Responsible party
- Sponsor
- Investigators
- Ante Anic, MD, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167434
- Sponsor's protocol ID
- FC-2022-01
- Status last verified
- Mar 2025
- First submitted
- 21 Nov 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation Voice Of the Heart Trial (First-in-Human Study)
- ClinicalTrials.gov ID
- NCT06167434
- Acronym / sponsor ID
- FC-2022-01
- Keywords
- Telemedicine, Cardiac Arrhythmia, ECG, PCG, Accelerometer, Cardiac monitor, Insertable cardiac monitor
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future Cardia, IncIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd.
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Future Cardia™ Insertable Cardiac Monitoring (ICM) SystemInsertable Cardiac Monitor Implant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Future Cardia™ Insertable Cardiac Monitoring (ICM) SystemThe Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion. | Device | Single Arm |
Primary outcome
Characterization of Insertion Procedure - Implantation: Insertion Success
Time frame: up to 24 weeks
Insertion Success. (Yes/No); Place Device into Pocket (Yes/No);
Characterization of Insertion Procedure - Implantation: Incision Size
Time frame: up to 24 weeks
Incision Size in millimeters (mm).
Characterization of Insertion Procedure - Implantation: Device Orientation
Time frame: up to 24 weeks
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: Duration of Insertion Procedure.
Time frame: up to 24 weeks
Duration of Insertion Procedure in minutes (min).
Characterization of Explant Procedure - Device removal: Removal Success
Time frame: up to 24 weeks
Removal Success (Yes/No)
Characterization of Explant Procedure - Device removal: Incision Size
Time frame: up to 24 weeks
Incision Size in millimeters (mm)
Characterization of Explant Procedure - Device removal: Duration of explant procedure
Time frame: up to 24 weeks
Duration of explant procedure in minutes (min).
Device and Procedural Safety over a period of 180 days
Time frame: up to 24 weeks
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
Time frame: up to 24 weeks
Assess the percentage of successful wireless transmissions from the system throughout the study duration (transmission successful, the transmission failed or transmission re-try).
4 secondary outcomes
Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.
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).
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.
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.
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Future Cardia Inc.WebsiteLink provided by the sponsor.
- Meditrial Europe Ltd.CROLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ante Anic, MD principal investigator
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Future Cardia™ Insertable Cardiac Monitoring (ICM) System in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Future Cardia, Inc at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Insertion Procedure - Implantation: Insertion Success (time frame: up to 24 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.