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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Na Homolce Hospital
  Praha Klanovice, Czechia Recruiting
• NCH Downtown Baker Hospital
  Naples, Florida, United States Enrolling by invitation
• University of Vermont Medical Center
  Burlington, Vermont, United States Enrolling by invitation
• Virginia Commonwealth University (VCU)
  Richmond, Virginia, United States Enrolling by invitation

Study contacts

• Study coordinator: Jim Foster, SysEng
• Email: jfoster@coremapmedical.com
• Phone: 6178723908

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

  This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.

  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

  This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 2 sites Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT07535268

• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

  This trial tests a combined procedure using the Volt PFA System and Amulet 2 to see if it safely and feasibly treats atrial fibrillation while also closing the left atrial appendage in adults with AF.

  Recruiting at 13 sites Abbott Medical Devices · Brussels, B CAP R and 15 other locations · NCT07523620

• Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

  This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.

  Recruiting Phase 4 Sir Run Run Shaw Hospital · Hangzhou and 4 other locations · NCT07508618

• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

  This study tests whether adding posterior wall isolation and superior vena cava isolation to pulmonary vein isolation with pulsed-field ablation helps people with persistent atrial fibrillation stay in rhythm.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07405359

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.