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History of Changes for Study: NCT03650556
Safety and Effectiveness of TactiCathâ„¢ Contact Force, Sensor Enabledâ„¢ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Latest version (submitted April 1, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 26, 2018 None (earliest Version on record)
2 October 2, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 5, 2018 Study Status and Study Design
4 December 17, 2018 Contacts/Locations and Study Status
5 January 17, 2019 Study Status and Contacts/Locations
6 January 30, 2019 Study Status and Study Identification
7 March 16, 2019 Contacts/Locations and Study Status
8 May 22, 2019 Contacts/Locations and Study Status
9 September 30, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 May 13, 2021 Recruitment Status and Study Status
11 January 18, 2022
Quality Control Review has not concluded Returned: February 9, 2022
Outcome Measures, Study Status, Document Section and Arms and Interventions
12 April 1, 2022 Outcome Measures, Study Status, Participant Flow, Document Section, Adverse Events and Baseline Characteristics
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Study NCT03650556
Submitted Date:  August 26, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: ABT-CIP-10239
Brief Title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Official Title: Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2018
Overall Status: Not yet recruiting
Study Start: August 2018
Primary Completion: May 2021 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: August 1, 2018
First Submitted that
Met QC Criteria:
August 26, 2018
First Posted: August 28, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
August 26, 2018
Last Update Posted: August 28, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Persistent Atrial Fibrillation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 158 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Ablation
Pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) in the persistent AF population.
Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of device and/or procedure-related SAEs.
[ Time Frame: Within 7 days of initial and repeat procedure ]

1. Incidence of device and/or procedure-related SAEs with onset within 7-days of the ablation procedure.
2. Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence.
[ Time Frame: Through 15 months ]

2. Freedom from atrial fibrillation (AF), atrial flutter (AFL) or atrial tachycardia (AT) recurrence through 15-months.
Secondary Outcome Measures:
1. Acute Procedural Success
[ Time Frame: Immediate post procedure ]

Acute procedural success is defined as confirmation of entrance block in all pulmonary veins
2. 15-month Success off of Antiarrhythmic Drugs
[ Time Frame: 15 months ]

Proportion of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
3. 15 Month Single Procedure Success
[ Time Frame: 15 months ]

Proportion of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time will be deemed an effectiveness failure in this analysis.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Laura Menck
Telephone: 651-756-2375
Email: laura.menck@abbott.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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