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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: GP ablation + PV isolation

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
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Tachyarrhythmia Recurrence in Participants	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.	0-5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Significant Ablation Procedure Related Complications	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.	0-1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Sunny Po, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 31, 2007
• First Posted (Estimate): January 2, 2008

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 010971