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

Paroxysmal Atrial Fibrillation Clinical Trial

— TactiCathPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310100
• Other study ID #: SJM-CIP-10030
• Status: Completed
• Phase: N/A
• Start date: January 21, 2015
• Est. completion date: September 17, 2021

Study information

• Verified date: September 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02088606

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 17, 2021
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• TactiCath Quartz treatment

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Cardiology Consultants of East Michigan	Flint	Michigan
United States	Glendale Memorial Hospital and Health Center	Glendale	California
United States	The Methodist Hospital	Houston	Texas
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Louisville	Louisville	Kentucky
United States	Centennial Medical Center	Nashville	Tennessee
United States	Mount Sinai Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Regional Cardiology Associates	Sacramento	California
United States	Providence Hospital	Southfield	Michigan
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)	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 compared to 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 s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.	12 Months post ablation
Primary	Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event	The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.	7 days