NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)

This study has been terminated.
(Enrollment stopped after CDRH Advisory Panel (Nov 20, 2008) recommended NAVISTAR® THERMOCOOL® catheter approval.)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00721149
First received: July 21, 2008
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.


Condition Intervention Phase
Heart Diseases
Arrhythmia
Atrial Fibrillation
Device: Radiofrequency Ablation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. [ Time Frame: From study day 91 through day 361 ] [ Designated as safety issue: No ]
    A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).

  • The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. [ Time Frame: within 7 days of ablation procedure ] [ Designated as safety issue: Yes ]
    Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.


Secondary Outcome Measures:
  • Percentage of Subjects Who Achieved Acute Success [ Time Frame: Day 91 - 361 ] [ Designated as safety issue: Yes ]
    Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.

  • 24-hour Holter Data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • TTM Data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Responded to Quality of Life Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    SF 36 Symptom Frequency and Severity Checklist


Enrollment: 10
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NaviStar ThermoCool Device: Radiofrequency Ablation
The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
  • Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.
  • Signed Patient Informed Consent Form.
  • Age 18 years or older.
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Exclusion Criteria:

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non- cardiac cause.
  • Previous ablation for atrial fibrillation.
  • Patients on amiodarone therapy at any time during the previous six (6) months.
  • AF episodes that last longer than 30 days and are terminated via cardioversion.
  • Any valvular cardiac surgical procedure.
  • CABG procedure within the last 180 days (six months).
  • Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
  • Documented left atrial thrombus on imaging (e.g. TEE).
  • History of a documented thromboembolic event within the past one (1) year.
  • Diagnosed atrial myxoma.
  • Presence of implanted ICD.
  • 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.
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  • Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
  • Acute illness or active systemic infection or sepsis.
  • Unstable angina.
  • Myocardial infarction within the previous 60 days (two months).
  • LVEF < 40%.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation (i.e. heparin or warfarin).
  • Contraindication to CT/MRA procedure.
  • Life expectancy less than 360 days (12 months).
  • Enrollment in an investigational study evaluating another device or drug.
  • Uncontrolled heart failure or NYHA class III or IV heart failure.
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  • Presence of a condition that precludes vascular access.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721149

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: David Wilber, MD Loyola University Medical Center Chicago
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00721149     History of Changes
Other Study ID Numbers: BWI03130TXA
Study First Received: July 21, 2008
Results First Received: February 8, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Ablation
Non-randomized

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014