Back to resultsNavi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GP ablation + PV isolation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Catheter Ablation, Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
GP + PVI ablation
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00584415
Brief Title
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Official Title
Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Isolation of the pulmonary veins at the LA-PV junction with the same or lower risk of pulmonary vein stenosis;
Creation of continuous, transmural linear left atrial lesions with the same or lower risk of thromboembolism;
These two factors will eliminate documented episodes of symptomatic sustained AF in patients with frequent (>3 episodes/month) or infrequent (<3 episodes/month);
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Catheter Ablation, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GP + PVI ablation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
GP ablation + PV isolation
Other Intervention Name(s)
Navi-Star ThermoCool Catheter, Biosense-Webster Inc.
Intervention Description
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Primary Outcome Measure Information:
Title
Atrial Tachyarrhythmia Recurrence in Participants
Description
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.
Time Frame
0-5 years
Secondary Outcome Measure Information:
Title
Total Number of Significant Ablation Procedure Related Complications
Description
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.
Time Frame
0-1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunny Po, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
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Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation
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