TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: TactiCath Quartz treatment

• Registration Number: NCT02310100
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Study Start: 2015-01-21
• Primary Completion: 2017-02
• Results First Submitted: 2019-01-31
• Results First Submitted QC: 2019-03-05
• Results First Posted: 2019-03-28
• Status Verified: 2021-09
• Study Completion: 2021-09-17
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TactiCath Quartz	TactiCath Quartz treatment	TactiCath Quartz treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event	7 days	The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.
Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)	12 Months post ablation	Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.

Trial Locations

Locations (20)

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

The Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Glendale Memorial Hospital and Health Center; 🇺🇸 Glendale, California, United States

Regional Cardiology Associates; 🇺🇸 Sacramento, California, United States

Providence Hospital; 🇺🇸 Southfield, Michigan, United States

Cardiology Consultants of East Michigan; 🇺🇸 Flint, Michigan, United States

Jackson Heart Clinic; 🇺🇸 Jackson, Mississippi, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Providence Heart and Vascular Institute; 🇺🇸 Portland, Oregon, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Cardiac Arrhythmia; 🇺🇸 Austin, Texas, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States