Paroxysmal Atrial Fibrillation
Conditions
Keywords
Catheter Ablation, Atrial Fibrillation
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.
Interventions
DEVICEGP ablation + PV isolation
All patients underwent GP ablation and PV isolation using the NaviStar ThermoCool ablation catheter
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Tachyarrhythmia Recurrence in Participants | 0-5 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Significant Ablation Procedure Related Complications | 0-1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PV Isolation + GP Ablation All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
Baseline characteristics
| Characteristic | PV Isolation + GP Ablation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 119 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 119 |
| serious Total, serious adverse events | 10 / 119 |
Outcome results
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.
Time frame: 0-5 years
Population: all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP Ablation + PV Isolation) | Atrial Tachyarrhythmia Recurrence in Participants | 37 participants |
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.
Time frame: 0-1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GP Ablation + PV Isolation) | Total Number of Significant Ablation Procedure Related Complications | 10 Complications |