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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584415
• Other study ID #: 010971
• Status: Completed
• Phase: N/A
• First received: December 20, 2007
• Last updated: July 1, 2014
• Start date: February 2004
• Est. completion date: February 2009

Study information

• Verified date: July 2014
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• GP ablation + PV isolation
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes