Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-07-25
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1- Mapping Only
For Phase 1, the goal is to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
CoreMap EP Mapping System Mapping
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
Phase 2- Map Guided Ablation
The Phase 2 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.
CoreMap EP Mapping System Mapping
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
CoreMap EP Mapping System Map-Guided Ablation
Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
Phase 3 - Map Guided Ablation
For Phase 3, the goal is the evaluation of a CoreMap guided tailored ablation strategy and to demonstrate chronic safety and effectiveness in de novo PerAF patients with the CoreMap EP Mapping System.
CoreMap EP Mapping System Mapping
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
CoreMap EP Mapping System Map-Guided Ablation
Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
Interventions
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CoreMap EP Mapping System Mapping
Endocardial mapping to collect and analyze high fidelity endocardial EGMs in patients with persistent and long-standing persistent AF.
CoreMap EP Mapping System Map-Guided Ablation
Initial development and evaluation of a map-guided tailored ablation strategy and to demonstrate safety and chronic efficacy of the CoreMap EP Mapping System.
Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
80 Years
ALL
No
Sponsors
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CoreMap Inc.
INDUSTRY
Responsible Party
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Locations
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Na Homolce Hospital
Praha Klanovice, , Czechia
Countries
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Central Contacts
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Other Identifiers
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CD001
Identifier Type: -
Identifier Source: org_study_id
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