Clinical trial NCT06167434: Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
Official title: Clinical Investigation of the Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation Voice Of the Heart Trial (First-in-Human Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Bradycardia
Ventricular Tachycardia
Asystole
Keywords: Telemedicine
Cardiac Arrhythmia
ECG
PCG
Accelerometer
Cardiac monitor
Insertable cardiac monitor
Lead sponsor: Future Cardia, Inc
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2023-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility 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.

Primary outcomes:
measure: Characterization of Insertion Procedure - Implantation: Insertion Success
timeFrame: Day 0
measure: Characterization of Insertion Procedure - Implantation: Incision Size
timeFrame: Day 0
measure: Characterization of Insertion Procedure - Implantation: Device Orientation
timeFrame: Day 0
measure: Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.
timeFrame: Day 0
measure: Characterization of Explant Procedure - Device removal: Removal Success
timeFrame: up to 6 months
measure: Characterization of Explant Procedure - Device removal: Incision Size
timeFrame: Up to 6 months
measure: Characterization of Explant Procedure - Device removal: Duration of explant procedure
timeFrame: Up to 6 months
measure: Device and Procedural Safety over a period of 180 days
timeFrame: 6 months
measure: Success of Wireless Transmissions over a period of 180 days
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.
timeFrame: 6 months
measure: Comparison of the Future Cardia™ ECG tracing and detection of arrhythmias with 7-day ECG recorder tracings or 24-hr Holter recording (optional, when available).
timeFrame: 6 months
measure: Usability: survey of the implanting physicians regarding the ease of implantation and use of the system for monitoring during follow-up.
timeFrame: 6 months
measure: Number of Serious Adverse Events (SAE) related to the Device or study procedure in patients who elect to continue monitoring using the ICM device after the 6-month study follow-up.
timeFrame: 2 Years
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split
Study officials:
affiliation: University Hospital Split
name: Ante Anic, MD
role: PRINCIPAL_INVESTIGATOR
References: