IRB Study Number 26-303
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
You would be asked to be in this research study if your doctor recommends that you undergo a redo cardiac ablation procedure for your atrial fibrillation, also known as “AF” or “Afib”. AF is an irregular and often rapid heart rhythm. The type of AF you would have is either persistent AF or paroxysmal AF. Persistent AF is AF that is ongoing for more than 7 days but less than one year. Paroxysmal AF is AF that lasts for at least 30 seconds but stops on its own or with intervention within 7 days.
This study involves several medical devices. Most of them have been approved by the U.S. Food and Drug Administration (FDA) for regular medical use. The Sphere-9™ Catheter when used to treat paroxysmal AF only is considered investigational, which means it has not been approved by the FDA for commercial use. The Sphere-9™ Catheter would be used during your ablation procedure.
You would be asked to complete the following visits: Baseline (in-person), Procedure, Pre-discharge (in-person), Day 7 (remote/ phone), Month 3 (in-person), Month 6 (remote/in-person), Month 12 (remote/in-person). Each in-person follow-up visit would last approximately 1 hour, and each remote/phone visit would last approximately 15-30 minutes. Testing at certain in-person visits would include procedures such as collection of Demographic data (such as age and gender), medical history, physical exam, ECG (tracing of your heart rhythm), imaging of your heart structure (like echocardiogram or CT scan), and quality of life questionnaires. Each questionnaire would take approximately 10 minutes to complete.
Your participation in the research would last approximately 12 months after your ablation procedure.
Inclusion Criteria
History of a single AF ablation procedure for Paroxysmal AF or Persistent AF within 3 years prior to enrollment
Documented evidence of symptomatic AF, Atrial Tachycardia (AT) or Atrial Flutter (AFL) recurrence at least 90 days after subject’s de novo ablation procedure, as demonstrated by:
o A physicians’ note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and
o At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment
Adults who are ≥18 years of age on the day of enrollment
Willing and able to comply with all study requirements and provide informed consent
Exclusion Criteria
- Continuous AF lasting for 12 months or longer
- Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices
- Planned left atrial appendage (LAA) closure procedure, cardiac transplantation or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- More than 1 previous AF ablation procedure
- Any prior surgical ablation procedure
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- Contraindication to or unwillingness to use systemic anticoagulation
- Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Presence of any pulmonary vein stents
- Known pre-existing pulmonary vein stenosis
- Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, or any prior atriotomy
- Moderate to severe mitral valve or aortic stenosis
- Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months preceding the consent date
- NYHA Class III or IV congestive heart failure
- Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE)
- Unstable angina
- Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen
- Rheumatic heart disease
- Presence of left atrial thrombus on imaging
- Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause)
- Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure
- Body mass index > 40 kg/m2
- 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
