Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation

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. Identifier: NCT00584415
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
The objective of this study is to demonstrate that the NAVI-STAR THERMO-COOL catheter can be used to safely and effectively reduce symptomatic episodes of paroxysmal atrial fibrillation in patients with frequent (>3 episodes/month) or infrequent <3 episodes/month)atrial fibrillation resistant to at least one Class I or Class III antiarrhythmic drug.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Device: GP ablation + PV isolation Not Applicable

Detailed Description:

The ability of a saline irrigated catheter to deliver RF energy at higher power with a lower electrode-tissue interface temperature, combined with the anatomical guidance of electroanatomical mapping should allow:

  1. Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
  2. Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
  3. These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
  4. Patients with interruption of the vagal response (sinus bradycardia or AV block) during stimulation at the sites of left atrial autonomic ganglionated plexi (GP) will have lower recurrence of atrial fibrillation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Study Start Date : February 2004
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: GP + PVI ablation
This study contains only one arm, which is GP ablation + PV antrum isolation. The intervention (GP ablation + PV isolation) was performed using ThermoCool Navistar catheters in all patients
Device: GP ablation + PV isolation
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Other Name: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.

Primary Outcome Measures :
  1. Atrial Tachyarrhythmia Recurrence in Participants [ Time Frame: 0-5 years ]
    Outcome is determined by recurrence of atrial tachyarrhythmia in participants. Outcome is measured by any atrial tachyarrhythmias recorded by 12-lead ECGs, Holter monitoring or event monitoring. Recurrence of atrial tachyarrhythmia is also measured by symptoms reported by patients. Symptoms include palpitations, dizziness, dyspnea and any AF-related symptoms that existed before AF ablation.

Secondary Outcome Measures :
  1. Total Number of Significant Ablation Procedure Related Complications [ Time Frame: 0-1 year ]
    Any complication directly related to the ablation procedure was included. These complications included pericardial effusion, cardiac tamponade, excessive bleeding requiring transfusion, phrenic nerve injury, atrio-esophageal fistula, vascular access complications, myocardial infarction and stroke.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age greater or equal to 18 years
  2. At least one documented episode of atrial fibrillation (AF) within the previous 6 months.
  3. Failure of at least one antiarrhythmic drug (Class I or III) defined as recurrence of AF or adverse effect.
  4. Informed consent obtained.

Exclusion Criteria:

  1. Left atrial thrombus
  2. Acute myocardial infarction within eight (8) weeks
  3. Atriotomy within eight (8) weeks
  4. Decompensated heart failure (unless the AF is thought to be a significant etiologic factor and AF ablation is clinically indicated)
  5. Pregnancy
  6. Ablation in a pulmonary vein within 4 months.
  7. Occurrence of perforation during an ablation procedure performed less than two months prior to the planned ablation date.
  8. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in the study.
  9. Enrolled in an investigational study evaluating another device or drug
  10. Unwilling to participate in the study or unavailable for follow-up visits.
  11. Incarcerated

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 identifier (NCT number): NCT00584415

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Sunny Po, MD University of Oklahoma

Responsible Party: University of Oklahoma Identifier: NCT00584415     History of Changes
Other Study ID Numbers: 010971
First Posted: January 2, 2008    Key Record Dates
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by University of Oklahoma:
Catheter Ablation
Atrial Fibrillation

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