TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.

Detailed Description
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This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.

Official Title
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Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: TactiCath SE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug Physician's note indicating recurrent self-terminating AF One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure At least 18 years of age Able and willing to comply with all trial 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: Persistent or long-standing persistent atrial fibrillation (AF) Four or more cardioversions in the past 12 months Active systemic infection Known presence of cardiac thrombus Implanted with implantable cardiac defibrillator (ICD) Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months Left atrial diameter > 5.0 cm Left ventricular ejection fraction < 35% New York Heart Association (NYHA) class III or IV Previous left atrial surgical or catheter ablation procedure Left atrial surgical procedure or incision with resulting scar Previous tricuspid or mitral valve replacement or repair Heart disease in which corrective surgery is anticipated within 6 months Bleeding diathesis or suspected procoagulant state Contraindication to long term antithromboembolic therapy Presence of any condition that precludes appropriate vascular access Renal failure requiring dialysis Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 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 Pregnant or nursing Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results 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 Patient is unlikely to survive the protocol follow up period of 12 months Body mass index > 40 kg/m2 Vulnerable subject

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TactiCath SE<br>Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. | Device: TactiCath SE<br>* Ablation to achieve pulmonary vein isolation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Serious Adverse Events | The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: Atrial-esophageal fistula AV block Cardiac Perforation/ Tamponade Death Diaphragmatic paralysis Gastroparesis Hospitalization Myocardial Infarction Pericarditis Pneumothorax Pulmonary edema Pulmonary vein stenosis Stroke Thromboembolism Transient ischemic attack Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint. | 30 days | 
| Number of Participants With Procedural Success | The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins | 0 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAF, paroxysmal atrial fibrillation, ablation