Overview

This trial is active, not recruiting.

Condition paroxysmal atrial fibrillation
Treatment tacticath quartz treatment
Sponsor St. Jude Medical
Start date December 2014
End date February 2017
Trial size 178 participants
Trial identifier NCT02310100, SJM-CIP-10030

Summary

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
TactiCath Quartz treatment
tacticath quartz treatment

Primary Outcomes

Measure
Freedom from symptomatic PAF, AFL, and AT
time frame: 12 Months post ablation

Secondary Outcomes

Measure
Procedure related Serious Adverse Event
time frame: 7 Day post ablation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I IV antiarrhythmic drug 2. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, trans-telephonic event monitor, telemetry strip, or implanted device 3. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history 4. Patient is 18 years of age or older 5. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits 6. Patient provides written informed consent prior to enrollment in the study Exclusion Criteria: 1. Persistent or long-standing persistent atrial fibrillation (AF) 2. Patient has had 4 or more cardioversions in the past 12 months. 3. Active systemic infection 4. Presence of implantable cardiac defibrillator (ICD) 5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months 6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months 7. Left atrial diameter > 5.0 cm 8. Left ventricular ejection fraction < 35% 9. New York Heart Association (NYHA) class III or IV 10. Previous left atrial ablation procedure, either surgical or catheter ablation 11. Patient has had a left atrial surgical procedure or incision with resulting scar 12. Previous tricuspid or mitral valve replacement or repair 13. Heart disease in which corrective surgery is anticipated within 6 months 14. Bleeding diathesis or suspected pro coagulant state 15. Contraindication to long term antithromboembolic therapy 16. Presence of any condition that precludes appropriate vascular access 17. Renal failure requiring dialysis 18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication 19. Contraindication to computed tomography and magnetic resonance angiography 20. 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 21. Positive pregnancy test results for female patients of childbearing potential 22. Patient has other anatomic or co morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results 23. 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 study 24. Patient is unlikely to survive the protocol follow up period of 12 months

Additional Information

Official title TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.