Evaluating a new cardiac monitor for patients with paroxysmal atrial fibrillation
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 testing a new heart monitor to see how well it works and if it’s safe for people with occasional episodes of atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Future Cardia, Inc Industry-sponsored |
| Locations | 1 site (Split) |
| Trial ID | NCT06167434 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the safety and performance of the Future Cardia™ Insertable Cardiac Monitor (ICM) in patients with paroxysmal atrial fibrillation. It is a first-in-human, prospective, multi-center, pre-market single-arm trial that will evaluate the insertion procedure, the device's sensing and detection capabilities, and the success of data transmission over a follow-up period of six months. The study will also monitor any complications related to the device or the procedure itself.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who have paroxysmal atrial fibrillation and are either candidates for ablation or require anti-arrhythmic drug treatment.
Not a fit: Patients who are scheduled for an MRI or have a contraindication to the Future Cardia implant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective monitoring solution for patients with paroxysmal atrial fibrillation, improving their management and outcomes.
How similar studies have performed: Other studies have shown promise with similar cardiac monitoring devices, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Split
- University Hospital of Split — Split, Croatia (Recruiting)
Study contacts
- Principal investigator: Ante Anic, MD — University Hospital Split
- Study coordinator: Jaeson Bang
- Email: jaeb@futurecardia.com
- Phone: +1 727 470 3466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.