Status:
RECRUITING
Endocardial Mapping with the CoreMap EP Mapping System
Lead Sponsor:
CoreMap Inc.
Conditions:
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a global, multi-site, prospective, feasibility study.
Detailed Description
The INvENI Study consists of three phases. For Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent and long-standing persistent AF. Fo...
Eligibility Criteria
Inclusion
- Subject has persistent or long-standing persistent AF, at the discretion of the investigator
- Subject is 18 to 80 years of age
- Patient scheduled for standard of care AF ablation
- Subject is able to provide written informed consent
- Subject is able and willing to complete all study procedures
Exclusion
- Any of the following within three months of enrollment:
- Myocardial infarction (MI)
- Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
- Confirmed thrombus on imaging
- Any of the following within six months of enrollment: a) Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy b) Thromboembolic event (stroke)
- Any of the following cardiac conditions:
- New York Heart Association (NYHA) IV
- Left ventricular ejection fraction (LVEF) \< 30%
- Carotid stenting or endarterectomy
- Atrial or ventricular septal closure or left atrial appendage closure
- Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator
- Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
- Unstable angina
- Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
- Moderate to severe mitral valve stenosis or other severe valvular disease
- Any blood clotting or bleeding abnormalities
- Contraindication to systemic anticoagulation
- AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
- Body mass index (BMI) \> 40 kg/m2
- Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
- Renal failure requiring dialysis or transplant
- Acute illness, active systemic infection, or sepsis
- Active drug or alcohol dependency
- Any contra-indication that may extend procedure time, at the discretion of the operator
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- Subject considered part of vulnerable population
- Life expectancy less than one year
- Employee of the study site or Sponsor
- Subjects who are currently enrolled in another study that would directly interfere with this study
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06529978
Start Date
July 25 2024
End Date
December 31 2026
Last Update
March 18 2025
Active Locations (1)
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1
Na Homolce Hospital
Praha Klanovice, Czechia