Status:
ACTIVE_NOT_RECRUITING
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Lead Sponsor:
Future Cardia, Inc
Collaborating Sponsors:
Meditrial Europe Ltd.
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 inser...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Exclusion criteria for the study procedure:
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06167434
Start Date
December 1 2023
End Date
December 1 2026
Last Update
August 8 2025
Active Locations (1)
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1
University Hospital of Split
Split, Croatia