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New treatment option for Persistent Atrial Fibrillation
Official title Endocardial Mapping With the CoreMap EP Mapping System
ClinicalTrials.gov ID: NCT06529978
What this study is testing
- What it's testing
- This is a global, multi-site, prospective, feasibility study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
- Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
- Subject is 18 to 80 years of age
- 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...
- Subject is able to provide written informed consent
You likely can't join if
- 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:
- Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
See the full eligibility criteria
- Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
- Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
- Subject is 18 to 80 years of age
- 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)
- Subject is able to provide written informed consent
- Subject is able and willing to complete all study procedures
- 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:
- Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
- Thromboembolic event (stroke)
- Any of the following cardiac conditions:
- New York Heart Association (NYHA) IV
- Left ventricular ejection fraction (LVEF) \< 30%
- Left atrial diameter \>55mm (anterioposterior) (Phase 3)
- 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; loop recorders are permitted.
- 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
- Hypertrophic cardiomyopathy or cardiac amyloidosis
- Cor pulmonale
- 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
- people who are currently enrolled in another study that would directly interfere with this study
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Florida, United States
- Burlington, Vermont, United States
- Richmond, Virginia, United States
- Praha Klanovice, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Florida, United States; Burlington, Vermont, United States; Richmond, Virginia, United States; Praha Klanovice, Czechia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.