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

NCT ID: NCT02310100

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-21
• Study Completion Date: 2021-09-17

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TactiCath Quartz

TactiCath Quartz treatment

Group Type: EXPERIMENTAL

TactiCath Quartz treatment

Intervention Type: DEVICE

Interventions

TactiCath Quartz treatment

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Ruffner, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Regional Cardiology Associates

Sacramento, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Cardiology Consultants of East Michigan

Flint, Michigan, United States

Providence Hospital

Southfield, Michigan, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Mount Sinai Hospital

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence Heart and Vascular Institute

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Centennial Medical Center

Nashville, Tennessee, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

The Methodist Hospital

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10030

Identifier Type: -

Identifier Source: org_study_id

NCT02088606

Identifier Type: -

Identifier Source: nct_alias