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



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:December 2014
End Date:February 2021

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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.


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
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Austin, Texas 78705
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22908
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Houston, Texas 77030
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Jackson, Mississippi 39216
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Kansas City, Kansas
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
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Nashville, Tennessee 37203
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New York, New York 10029
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Portland, Oregon 97220
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Sacramento, California 95819
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16001 W 9 Mile Rd
Southfield, Michigan 48075
(248) 849-3000
Providence Hospital St. John Providence Health System is comprised of five hospitals plus more than...
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101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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