Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02310100
Recruitment Status : Active, not recruiting
First Posted : December 5, 2014
Results First Posted : March 28, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: N/A
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
Actual Study Start Date : January 21, 2015
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. Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (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 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.

  2. Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event [ Time Frame: 7 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov identifier (NCT number): NCT02310100


Locations
Show Show 20 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Study Director: Kristin Ruffner, PhD Abbott
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02310100    
Obsolete Identifiers: NCT02088606
Other Study ID Numbers: SJM-CIP-10030
First Posted: December 5, 2014    Key Record Dates
Results First Posted: March 28, 2019
Last Update Posted: April 9, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes