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

NCT ID: NCT00584415

Last Updated: 2014-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2009-02-28

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.

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

GP ablation + PV isolation

Intervention Type: DEVICE

All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter

Interventions

GP ablation + PV isolation

All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter

Intervention Type: DEVICE

Other Intervention Names

Navi-Star ThermoCool Catheter, Biosense-Webster Inc.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunny Po, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

010971

Identifier Type: -

Identifier Source: org_study_id