Last updated: October 7, 2022
Sponsor: Cardialen, Inc.
Overall Status: Terminated
Phase
N/A
Condition
Chest Pain
Arrhythmia
Atrial Fibrillation
Treatment
N/AClinical Study ID
NCT05055921
CL007 (US)
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female between 18 and 80 years of age
- Willing and able to comply with the study protocol, provide a written informed consent
- Currently indicated for atrial catheter ablation due to paroxysmal or early persistentatrial fibrillation
- Current treatment and compliance with standard anticoagulation regimen, includinguninterrupted OAC, with acceptable coagulation status, as determined by the PrincipalInvestigator
Exclusion
Exclusion Criteria: The subject must not meet any of the following exclusion criteria:
- Life expectancy of 1 year or less
- AF due to reversible causes (e.g., hyperthyroidism, valve disease)
- History of DC Cardioversion which failed to convert to AF to Normal Sinus Rhythm
- Currently in AF for more than 3 months continuously
- Chronic, long-standing persistent, or permanent atrial fibrillation
- Allergy or contraindication to anticoagulation therapy
- Presence of intracardiac thrombus (confirmed with TEE or ICE)
- Existing Left Atrial Appendage closure device
- Severely Dilated Left Atrium >5cm
- LVEF<35%
- NYHA Class III or IV heart failure at the time of enrollment
- History of embolic stroke, Transient Ischemic Attack (TIA) or other thromboembolicevent within the preceding 3 months.
- Known hyper-coagulable state that increases risk of thrombus
- History of myocardial infarction or coronary revascularization within the preceding 3months.
- History of sustained ventricular arrhythmia or cardiac arrest
- Presence of chronically implanted lead in the CS
- Presence of ventricular assist device, including intra-aortic balloon pump
- Documented bradycardia (<40 BPM) at the time of the study
- Morbid obesity: BMI>39 kg/m2
- Presence of any prosthetic cardiac valve
- History of significant tricuspid valvular disease requiring surgery
- Moderate to severe mitral valve regurgitation (>40% regurgitation fraction)
- Cognitive or mental health status that would interfere with study participation andproper informed consent
- Cardiovascular anatomical defects that would complicate placement of the stimulationleads required by the protocol, including congenital heart disease and cardiac veinanomalies per the Investigator's discretion
- Pregnancy confirmed by test within 7 days of procedure.
- Inability to pass catheters to heart due to vascular limitations
- Cardiovascular surgery or intervention within 1 month prior to enrollment or plannedfor up to 1 month after enrollment (other than the planned treatment procedure)
- Active endocarditis
- Any other medical condition which may affect the outcome of this study or safety ofthe subject as determined by the investigator
- History of hemodynamic compromise due to valvular heart disease
- Unstable CAD as determined by the investigator
- Severe proximal three-vessel or left main coronary artery disease withoutrevascularization as determined by the investigator
- History of Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia,Congenital Heart Anomaly, Cardiac Amyloidosis or Cardiac Sarcoidosis
Study Design
Total Participants: 6
Study Start date:
February 28, 2022
Estimated Completion Date:
October 01, 2022
Study Description
Connect with a study center
Minneapolis Veterans Administration Hospital
Minneapolis, Minnesota 55417
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available

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