Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-… (NCT06167434) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Future Cardiaâ„¢ 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 Cardiaâ„¢ ICM.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
✕. Compromised immune system or at high risk of developing an infection.
✕. Active systemic infection or history of any infection within the last 30 days.
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
Timeframe: up to 24 weeks
8
Device and Procedural Safety over a period of 180 days
✕. 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.
Timeframe: up to 24 weeks
9
Success of Wireless Transmissions over a period of 180 days