Status:
COMPLETED
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
Lead Sponsor:
Abbott Medical Devices
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 treatm...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03354663
Start Date
December 11 2017
End Date
October 30 2019
Last Update
October 11 2023
Active Locations (21)
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1
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
2
Scripps Health
La Jolla, California, United States, 92037
3
Sequoia Hospital
Redwood City, California, United States, 94062
4
South Denver Cardiology Associates, P.C.
Littleton, Colorado, United States, 80120