IRB Study Number 24-1140
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study because you have a heart condition called atrial fibrillation (a condition where the heart beats irregularly and/or rapidly). You are being invited by your doctor to take part in this research study evaluating the investigational TactiFlex PFA System because your doctor has determined that this ablation system could be beneficial for treatment of your atrial fibrillation condition. The purpose of this study is to find out if the TactiFlex PFA System (the device that is being studied) is safe and effective in treating your abnormal heartbeat.
There is a procedure called catheter ablation. This procedure treats abnormal heart rhythms. During this procedure, doctors create small scars in the heart. These scars block abnormal heart rhythms. Other catheters and ablation systems are approved to treat abnormal heart rhythms. These systems use different energy forms. These energy forms are radiofrequency (RF) energy (heat), cryothermy (freezing), and pulsed field (PF) (non-heating electric pulses). The TactiFlex PFA System can use either PF or RF energy to create scars. It is approved for use in the US and EU for delivering RF energy to treat abnormal heart rhythms. In this study, a modified version (the TactiFlex PFA catheter) delivers PF or RF energy which is investigational and not currently FDA approved. Other catheters approved for delivering PF energy have a different shaped tip and create scars of a different size and shape. The TactiFlex PFA uses a pinpoint mechanism to create one small scar at a time. Other catheters have a larger foot print. The TactiFlex PFA catheter can also deliver two different energies (PF or RF) through one catheter.
You will be asked to undergo a cardiac ablation using the TactiFlex PFA system and complete follow-up study visits before discharge and at around 7-Days (in-person), 5-Weeks (phone call), 3-Months (phone), 6-Months (in-person), and 12-Months (in-person).
Inclusion Criteria
- Documented symptomatic paroxysmal atrial fibrillation (PAF)
- Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
- At least 18 years of age
- Able and willing to comply with all trial requirements including pre-procedure, post-procedure, and follow-up testing and requirements
- Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site
Exclusion Criteria
- Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
- Known presence of cardiac thrombus
- Left ventricular ejection fraction (LVEF) < 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure
- New York Heart Association (NYHA) class III or IV heart failure
- Body mass index > 40 kg/m2
- Pregnant or nursing
- Patients who have had a ventriculotomy or atriotomy within the preceding 28 days of procedure
- Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
- Stroke or TIA (transient ischemic attack) within the last 90 days
- Heart disease in which corrective surgery is anticipated within 180 days after procedure
- History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
- Contraindication to long-term anti-thromboembolic therapy
- Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
- Presence of an implantable therapeutic cardiac device including permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) or planned implant of such a device for any time during the follow-up period. Presence of an implantable loop recorder is acceptable as long as it is removed prior to insertion of the investigational device.
- Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
