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

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.

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.

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.