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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02310100
Recruitment Status : Active, not recruiting
First Posted : December 5, 2014
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: TactiCath Quartz treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study
Study Start Date : December 2014
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TactiCath Quartz
TactiCath Quartz treatment
Device: TactiCath Quartz treatment

Primary Outcome Measures :
  1. Freedom from symptomatic PAF, AFL, and AT [ Time Frame: 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 is higher than 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 new ADD for the documented symptomatic atrial arrhythmia following the blanking period.

Secondary Outcome Measures :
  1. Procedure related Serious Adverse Event [ Time Frame: 7 Day post ablation ]
    Rate of device or procedure related Serious Adverse Events (SAEs) occurring within 7 days of the index procedure or hospital discharge, whichever is later, is below a stated performance goal.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02310100

United States, California
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Regional Cardiology Associates
Sacramento, California, United States, 95819
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Cardiology Consultants of East Michigan
Flint, Michigan, United States, 48532
Providence Hospital
Southfield, Michigan, United States, 48075
United States, Mississippi
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Providence Heart and Vascular Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Centennial Medical Center
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78704
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT02310100     History of Changes
Other Study ID Numbers: SJM-CIP-10030
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes