Trial Outcomes & Findings for Navi-Star Thermo-Cool Catheter For Ablation of Atrial Fibrillation (NCT NCT00584415)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

0-5 years

Results posted on

2014-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	GP Ablation + PV Isolation All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
Overall Study STARTED	119
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	GP Ablation + PV Isolation All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
Overall Study Adverse Event	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PV Isolation + GP Ablation n=119 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants
Region of Enrollment United States	119 participants n=5 Participants

PRIMARY outcome

Timeframe: 0-5 years

Population: all patients referred for paroxysmal AF ablation between 1-2004 and 12-2005 were included

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.

Outcome measures

Outcome measures
Measure	GP Ablation + PV Isolation) n=119 Participants All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
Atrial Tachyarrhythmia Recurrence in Participants	37 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GP Ablation + PV Isolation) n=119 Participants All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
Total Number of Significant Ablation Procedure Related Complications	10 Complications

Adverse Events

Experimental Arm (GP Ablation + PV Antrum Isolation)

Serious events: 10 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Arm (GP Ablation + PV Antrum Isolation) n=119 participants at risk All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
Cardiac disorders serious	8.4% 10/119 • Number of events 10 • The adverse effects were collected within the 1st year after ablation.
Cardiac disorders pericardial effusion/tamponade	5.9% 7/119 • Number of events 7 • The adverse effects were collected within the 1st year after ablation.
Nervous system disorders stroke	0.84% 1/119 • Number of events 1 • The adverse effects were collected within the 1st year after ablation.
Nervous system disorders phrenic nerve injury	0.84% 1/119 • Number of events 1 • The adverse effects were collected within the 1st year after ablation.
Gastrointestinal disorders death	0.84% 1/119 • Number of events 1 • The adverse effects were collected within the 1st year after ablation.

Other adverse events

Other adverse events
Measure	Experimental Arm (GP Ablation + PV Antrum Isolation) n=119 participants at risk All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
Vascular disorders groin hematoma	5.0% 6/119 • Number of events 6 • The adverse effects were collected within the 1st year after ablation.
Infections and infestations pneumonia	2.5% 3/119 • Number of events 3 • The adverse effects were collected within the 1st year after ablation.

Additional Information

Sunny Po, MD., Study Principal Investigator

University of Oklahoma Health Sciences Center

Phone: 405-271-9696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place