Endocardial Mapping with the CoreMap EP Mapping System

Launched by COREMAP INC. · Jul 27, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special mapping system called the CoreMap EP Mapping System to help treat a heart condition known as persistent atrial fibrillation (AF). Atrial fibrillation is an irregular heartbeat that can lead to various health issues. The study is currently recruiting participants aged between 18 and 80 who have been diagnosed with persistent AF and are scheduled to undergo a standard procedure called ablation, which aims to restore a normal heart rhythm.

To be eligible for this study, participants need to be in good health without certain recent heart issues or serious conditions that could complicate the procedure. If chosen to participate, individuals can expect to take part in specific tests and procedures related to their AF treatment while being closely monitored by healthcare professionals. This trial is important as it may provide insights into improving treatment methods for atrial fibrillation, ultimately benefiting patients in the future.

Gender

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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