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

NCT00584415 | Completed Results

• 1 other identifier: 010971
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Catheter Ablation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Number of Significant Ablation Procedure Related Complications

  0-1 year

Study Arms (1)

GP + PVI ablation

ACTIVE COMPARATOR

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

Interventions

GP ablation + PV isolation DEVICE

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

Also known as: Navi-Star ThermoCool Catheter, Biosense-Webster Inc.

GP + PVI ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sunny Po, MD., Study Principal Investigator
• Organization: University of Oklahoma Health Sciences Center

sunny-po@ouhsc.edu

405-271-9696

Study Officials

• Sunny Po, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 2, 2008
• Study Start: February 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-07

Locations

US (1)