Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation



Status:Recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:September 28, 2018
End Date:May 2021
Contact:Laura Menck
Email:laura.menck@abbott.com
Phone:651-756-2375

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Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)

This clinical investigation is intended to demonstrate the safety and effectiveness of the
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac
electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic
persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency
(RF) generator and three-dimensional mapping system. This clinical investigation will be
conducted under an investigational device exemption (IDE) and is intended to support market
approval of the TactiCath SE ablation catheter for the treatment of drug refractory,
symptomatic persistent atrial fibrillation in the United States.


Inclusion Criteria:

1. Patient must provide written informed consent prior to any clinical investigation
related procedure.

2. Documented symptomatic persistent AF, which is defined as continuous AF sustained
beyond 7-days and less than 1-year that is documented by (1) a physician's note and
(2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF

3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as
evidenced by recurrent symptomatic AF

4. Age 18 years or older

5. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements

Exclusion Criteria:

1. Continuous AF > 12 months (longstanding persistent AF)

2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a
previous procedure that required an incision in the left atrium with resulting scar

3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial
procedure

4. CABG surgery within the 6-months (180-days) prior to the initial procedure

5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or
replacement and/or presence of a prosthetic or mechanical valve)

6. Any carotid stenting or endarterectomy

7. Documented or known left atrial thrombus on imaging

8. Left atrial diameter > 50 mm (parasternal long axis view or by CT)

9. Left ventricular ejection fraction < 40%

10. Unable to take anticoagulation medication due to contraindication or intolerance

11. History of blood clotting or bleeding abnormalities

12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI) within the 3-months (90-days) prior to the initial procedure

13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior
to the initial procedure

14. Rheumatic heart disease

15. Uncontrolled heart failure or NYHA functional class III or IV

16. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥
50%, and/or effective regurgitant orifice area ≥ 0.40cm2)

17. Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365
days) following the initial ablation procedure

18. Unstable angina at the time of the initial procedure

19. Acute illness or active systemic infection or sepsis

20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication,
major surgical procedure in the preceding 3-months, or other reversible or non-cardiac
cause

21. Diagnosed atrial myxoma

22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac
resynchronization therapy-defibrillator (CRT-D)

23. Significant 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 chronic symptoms

24. Significant congenital anomaly or other anatomic or comorbid medical problem that in
the opinion of the investigator would preclude enrollment in this study or compliance
with the follow-up requirements or impact the scientific soundness of the clinical
trial results

25. Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period

26. Enrollment in an investigational study evaluating another device, biologic, or drug
that may interfere with this clinical investigation at the time of the initial
procedure or within 30 days prior to the initial procedure

27. Presence of any condition that precludes appropriate vascular access or manipulation
of catheter

28. Life expectancy less than 12-months

29. Body mass index > 40 kg/m2

30. Known sensitivity to contrast media (if needed during the procedure) that cannot be
controlled with pre-medication

31. Renal failure requiring dialysis

32. Vulnerable subject

33. History of atriotomy or ventriotomy

34. Implanted endocardial left atrial appendage occlusion device
We found this trial at
18
sites
Jackson, Mississippi 39216
Principal Investigator: Judson Colley, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Moussa Monsour, MD
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Boston, MA
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Adelaide, South Australia
Principal Investigator: Prash Sanders
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Adelaide,
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Atlanta, Georgia 30322
Principal Investigator: David DeLurgio, MD
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Atlanta, GA
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Austin, Texas 78705
Principal Investigator: Andrea Natale, MD
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Austin, TX
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Birmingham, Alabama 35249
Principal Investigator: Hugh Thomas McElderry, MD
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Birmingham, AL
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jeffrey Winterfield, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Christine Tanaka-Esposito, MD
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Jonesboro, Arkansas 72401
Principal Investigator: Devi Nair, MD
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Jonesboro, AR
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La Jolla, California 92037
Principal Investigator: Douglas Gibson, MD
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La Jolla, CA
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Little Rock, Arkansas 72211
Principal Investigator: Monica Lo, MD
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Little Rock, AR
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Littleton, Colorado 80120
Principal Investigator: Sri Sundaram, MD
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Littleton, CO
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Sammy Khatib, MD
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10016
Principal Investigator: Larry Chinitz, MD
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New York, NY
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Usman Siddiqui, MD
Florida Hospital Florida Hospital is one of the country
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Plano, Texas 75093
Principal Investigator: Adam Shapira, MD
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Redwood City, California 94062
Principal Investigator: Roger Winkle, MD
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Redwood City, CA
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Saint Louis, Missouri 63110
Principal Investigator: Daniel Cooper, MD
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Saint Louis, MO
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