Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-… (NCT06167434) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Croatia30 participantsStarted 2023-12-01
Plain-language summary
This study is a first-in-human, prospective, multi-center, pre-market single-arm clinical trial to evaluate the Future Cardia™ ICM.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization of Insertion Procedure - Implantation: Insertion Success
Timeframe: up to 24 weeks
2
Characterization of Insertion Procedure - Implantation: Incision Size
Timeframe: up to 24 weeks
3
Characterization of Insertion Procedure - Implantation: Device Orientation
Timeframe: up to 24 weeks
4
Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.
Timeframe: up to 24 weeks
5
Characterization of Explant Procedure - Device removal: Removal Success
Timeframe: up to 24 weeks
6
Characterization of Explant Procedure - Device removal: Incision Size
Timeframe: up to 24 weeks
7
Characterization of Explant Procedure - Device removal: Duration of explant procedure
. 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.
8
Device and Procedural Safety over a period of 180 days
Timeframe: up to 24 weeks
9
Success of Wireless Transmissions over a period of 180 days