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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00584415
First received: December 20, 2007
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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 Intervention
Paroxysmal Atrial Fibrillation
Device: GP ablation + PV isolation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Atrial Tachyarrhythmia Recurrence in Participants [ Time Frame: 0-5 years ] [ Designated as safety issue: Yes ]
    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:
  • Total Number of Significant Ablation Procedure Related Complications [ Time Frame: 0-1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 119
Study Start Date: February 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00584415

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00584415     History of Changes
Other Study ID Numbers: 010971
Study First Received: December 20, 2007
Results First Received: July 5, 2013
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
Catheter Ablation
Atrial Fibrillation

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

ClinicalTrials.gov processed this record on August 01, 2014