Mapping the heart's electrical signals in patients with persistent atrial fibrillation

Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol

This study is testing a new mapping system to see if it can help doctors better treat patients with ongoing atrial fibrillation by guiding a tailored heart procedure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 245 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: CoreMap Inc. (Industry-sponsored)
• Locations: 3 sites (Naples, Florida and 2 other locations)
• Trial ID: NCT06529978 on ClinicalTrials.gov

What this trial studies

This global, multi-site feasibility study aims to evaluate the CoreMap EP Mapping System in patients with persistent and long-standing persistent atrial fibrillation (AF). The study consists of three phases: the first phase focuses on collecting and analyzing high fidelity endocardial electrograms (EGMs), the second phase involves developing and assessing a CoreMap-guided tailored ablation strategy, and the third phase evaluates the safety and effectiveness of this strategy in new patients with persistent AF. The study will involve standard care AF ablation procedures guided by the CoreMap system.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with persistent or long-standing persistent atrial fibrillation scheduled for standard AF ablation.

Not a fit: Patients with recent myocardial infarction, significant cardiac conditions, or those who have undergone recent cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with persistent atrial fibrillation, potentially enhancing their quality of life.

How similar studies have performed: Other studies have shown promise in using advanced mapping techniques for atrial fibrillation, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
2. Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
3. Subject is 18 to 80 years of age
4. Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
5. Subject is able to provide written informed consent
6. 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:

   1. Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
   2. 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. Left atrial diameter \>55mm (anterioposterior) (Phase 3)
   4. Carotid stenting or endarterectomy
   5. Atrial or ventricular septal closure or left atrial appendage closure
   6. Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
   7. Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
   8. Unstable angina
   9. Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
   10. Moderate to severe mitral valve stenosis or other severe valvular disease
   11. 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. Hypertrophic cardiomyopathy or cardiac amyloidosis
12. Cor pulmonale
13. Any contra-indication that may extend procedure time, at the discretion of the operator
14. 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
15. Subject considered part of vulnerable population
16. Life expectancy less than one year
17. Employee of the study site or Sponsor
18. Subjects who are currently enrolled in another study that would directly interfere with this study

Where this trial is running

Naples, Florida and 2 other locations

• NCH Downtown Baker Hospital — Naples, Florida, United States (Enrolling_by_invitation)
• University of Vermont Medical Center — Burlington, Vermont, United States (Enrolling_by_invitation)
• Na Homolce Hospital — Praha Klanovice, Czechia (Recruiting)

Study contacts

• Study coordinator: Jim Foster, SysEng

Conditions Persistent Atrial Fibrillation