- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167434
Future Cardia™ Insertable Cardiac Monitor in Subjects With Paroxysmal Atrial Fibrillation (First-in-Human Study)
January 21, 2024 updated by: Future Cardia, Inc
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monica Tocchi, MD,PhD
- Phone Number: +1 646 933 1025
- Email: m.tocchi@meditrial.net
Study Contact Backup
- Name: Jaeson Bang
- Phone Number: +1 727 470 3466
- Email: jaeb@futurecardia.com
Study Locations
-
-
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Split, Croatia
- Recruiting
- University Hospital of Split
-
Contact:
- Ante Anic, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
Insertable Cardiac Monitor Implant.
|
The Future Cardia™ ICM procedure will be performed as a stand-alone procedure for subcutaneous insertion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of Insertion Procedure - Implantation: Insertion Success
Time Frame: Day 0
|
Insertion Success. (Yes/No)
|
Day 0
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Characterization of Insertion Procedure - Implantation: Incision Size
Time Frame: Day 0
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Incision Size in millimeters (mm).
|
Day 0
|
Characterization of Insertion Procedure - Implantation: Device Orientation
Time Frame: Day 0
|
Device Orientation: Location between the suprasternal notch and the left nipple, (position A); or left parasternal region (position B) or left sub-mammary position can be used (position C).
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Day 0
|
Characterization of Insertion Procedure - Implantation: Duration of Insertion Procedure.
Time Frame: Day 0
|
Duration of Insertion Procedure in minutes (min).
|
Day 0
|
Characterization of Explant Procedure - Device removal: Removal Success
Time Frame: up to 6 months
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Removal Success (Yes/No)
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up to 6 months
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Characterization of Explant Procedure - Device removal: Incision Size
Time Frame: Up to 6 months
|
Incision Size in millimeters (mm)
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Up to 6 months
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Characterization of Explant Procedure - Device removal: Duration of explant procedure
Time Frame: Up to 6 months
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Duration of explant procedure in minutes (min).
|
Up to 6 months
|
Device and Procedural Safety over a period of 180 days
Time Frame: 6 months
|
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6 months
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Success of Wireless Transmissions over a period of 180 days
Time Frame: 6 months
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Assess the percentage of successful wireless transmissions from the system throughout the study duration (transmission successful, the transmission failed or transmission re-try).
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the sensing quality of Future Cardia™ ICM, through assessment of the ECG signal by two independent electrophysiologists.
Time Frame: 6 months
|
ECG signal Assessment.
|
6 months
|
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).
Time Frame: 6 months
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Comparison of the Future Cardia™ ECG tracing and detection of arrhythmias with 7-day ECG recorder tracings or 24-hr Holter recording.
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6 months
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Usability: survey of the implanting physicians regarding the ease of implantation and use of the system for monitoring during follow-up.
Time Frame: 6 months
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Usability Survey
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6 months
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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.
Time Frame: 2 Years
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Long-term safety in Post study follow-up (> 6 months up to 2 years).
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ante Anic, MD, University Hospital Split
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
December 4, 2023
First Posted (Actual)
December 12, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FC-2022-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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