Clinical trial NCT06529978: Endocardial Mapping with the CoreMap EP Mapping System
Official title: Endocardial Mapping with the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: CoreMap Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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. For Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System. For Phase 3, the goal is the evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate both chronic safety and effectiveness in de novo PerAF patients.

Eligibility criteria: Inclusion Criteria:

1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator
2. Subject is 18 to 80 years of age
3. Patient scheduled for standard of care AF ablation
4. Subject is able to provide written informed consent
5. Subject is able and willing to complete all study procedures

Exclusion Criteria:

1. Any of the following within three months of enrollment:

   1. Myocardial infarction (MI)
   2. Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
   3. Confirmed thrombus on imaging
2. Any of the following within six months of enrollment: a) Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy b) Thromboembolic event (stroke)
3. Any of the following cardiac conditions:

   1. New York Heart Association (NYHA) IV
   2. Left ventricular ejection fraction (LVEF) \< 30%
   3. Carotid stenting or endarterectomy
   4. Atrial or ventricular septal closure or left atrial appendage closure
   5. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator
   6. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
   7. Unstable angina
   8. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
   9. Moderate to severe mitral valve stenosis or other severe valvular disease
   10. Any blood clotting or bleeding abnormalities
4. Contraindication to systemic anticoagulation
5. AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
6. Body mass index (BMI) \> 40 kg/m2
7. Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
8. Renal failure requiring dialysis or transplant
9. Acute illness, active systemic infection, or sepsis
10. Active drug or alcohol dependency
11. Any contra-indication that may extend procedure time, at the discretion of the operator
12. 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
13. Subject considered part of vulnerable population
14. Life expectancy less than one year
15. Employee of the study site or Sponsor
16. Subjects who are currently enrolled in another study that would directly interfere with this study

Primary outcomes:
measure: Phases 1 and Phase 2 Primary Endpoint:
timeFrame: 7 days
measure: Phase 2 and Phase 3 Primary Effectiveness Endpoint:
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Phase 1 Secondary Endpoint:
timeFrame: perioperatively/periprocedurally
measure: Phase 2 Secondary Endpoints:
timeFrame: perioperatively/periprocedurally
measure: Phase 3 Secondary Endpoints:
timeFrame: perioperatively/periprocedurally
Other outcomes:
Locations:
city: Praha - Klanovice
country: Czechia
facility: Na Homolce Hospital
Study officials:
References: