Clinical trial NCT02310100: TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
Official title: TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The TactiCath Quartz PAS is a prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation.

Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (Class I-IV) will be screened for enrollment. Patients who meet the study entry criteria and sign the patient informed consent form will be enrolled and treated following the standard of care at each study site.

After the index procedure, subjects will be followed for a total of 60 months. During the 3-month blanking period following ablation, subjects may undergo up to 2 repeat ablation procedures (up to 10 days prior to end of the blanking period) using the same device used during ablation. Subjects will be evaluated at pre-discharge, at 7 days, at 3, 6 and 12 months post-index procedure and then yearly thereafter. Subjects will complete Holter monitoring at 3- and 6- months post index ablation procedure and at yearly intervals beginning at 12 months post-index ablation procedure.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)
timeFrame: 12 Months post ablation
measure: Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Health Center
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: Abbott
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: