A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
- Conditions
- Atrial Fibrillation (AF)Atrial ArrhythmiaParoxysmal AFDrug Refractory Paroxysmal Atrial Fibrillation
- Registration Number
- NCT06676072
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
- Detailed Description
This is a pre-market, prospective, single-arm, non-randomized, multicenter clinical study to demonstrate safety and effectiveness for the treatment of symptomatic, recurrent, drug-refractory PAF.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 188
-
Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows:
- Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
- One electrocardiographically documented PAF episode within 12 months prior to enrollment.
NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
-
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.
- 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 atrial diameter (LAD) > or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
- Left ventricular ejection fraction (LVEF) < or equal to 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 > or equal to 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
- Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- Previous left atrial surgical or left atrial catheter ablation procedure (including left atrial appendage (LAA) closure device)
- Plans to have an LAA closure device implanted during the follow-up period
- Presence of any condition that precludes appropriate vascular access
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
- Previous tricuspid or mitral valve replacement or repair
- Patients with prosthetic valves
- Patients with a myxoma
- Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- Stent, constriction, or stenosis in a pulmonary vein
- Rheumatic heart disease
- Hypertrophic cardiomyopathy
- Active systemic infection
- Renal failure requiring dialysis
- Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- 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 without pre-approval from this study Sponsor
- Unlikely to survive the protocol follow up period of 12 months
- Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Individuals without legal authority
- Individuals unable to read or write
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure). 7 days Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure 12 months
- Secondary Outcome Measures
Name Time Method Symptomatic Effectiveness 12 months Freedom from documented symptomatic AF/AF/AT episodes of greater than 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM or Holter monitor devices after the index ablation procedure.
AAD-Free Effectiveness 12 months Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of \> 30 seconds duration that are documented by protocol-specific 12-lead ECG, TTM, or Holter monitor after the index ablation procedure. Any use of Class I or III antiarrythmic drugs after the 90-day blanking period will count as a therapy failure in the analysis
Trial Locations
- Locations (32)
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Mercy Hospital
🇺🇸Miami, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Kansas City Cardiac Arrhythmia Research Foundation
🇺🇸Overland Park, Kansas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Heart Rhythm of Mississippi, Research Division
🇺🇸Flowood, Mississippi, United States
Bryan Heart Medical Center
🇺🇸Lincoln, Nebraska, United States
New York University Hospital
🇺🇸New York, New York, United States
New York Presbyterian Hospital/Cornell University
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
🇺🇸Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
🇺🇸Austin, Texas, United States
Ocelot Medical Research Group
🇺🇸Dallas, Texas, United States
Medical City Fort Worth
🇺🇸Fort Worth, Texas, United States
Houston Methodist The Woodlands Hospital
🇺🇸Shenandoah, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
The Heart Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
KH Wiener Neustadt
🇦🇹Wiener Neustadt, L Austr, Austria
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Dzukija, Lithuania
Erasmus Medical Center - Thoraxcenter
🇳🇱Rotterdam, S Holln, Netherlands