Persistent Atrial Fibrillation
Conditions
Keywords
ablation, atrial fibrillation, Radio frequency
Brief summary
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.
Interventions
DEVICEMedtronic Phased RF Ablation System
Phased RF ablation
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment with Phased RF Ablation System
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* History of symptomatic persistent or long-standing persistent atrial fibrillation * Failure of at least one anti-arrhythmic drug
Exclusion criteria
* Structural heart disease * Prior ablation in left atrium for AF * Known sensitivities (or allergy) to heparin, warfarin, contrast media * Contraindicated for MRI * Invasive cardiovascular procedure performed or planned within 3 month period of ablation procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedure and/or Device Related Stroke | 30 days | A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-month Post-procedure Effectiveness | 6 months | For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG |
| Number of Participants With Acute Procedural Success | 30 minutes | Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion) |
| Number of Participants With Pulmonary Vein Stenosis | 3 months | Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure |
Countries
Canada, Hungary, Netherlands, United Kingdom, United States
Participant flow
Recruitment details
The first subject was enrolled on 05 November 2013 and the first Phased RF procedure occurred on 17 December 2013. Enrollment into the VICTORY AF study was closed on 26 June 2016 prior to reaching the target sample size due to slower than expected enrollment rate.
Participants by arm
| Arm | Count |
|---|---|
| Ablation Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Enrollment | Adverse Event | 1 |
| Enrollment | Lost to Follow-up | 1 |
| Enrollment | Other | 1 |
| Enrollment | Physician Decision | 3 |
| Enrollment | Protocol Violation | 46 |
| Enrollment | Study closed | 8 |
| Enrollment | Withdrawal by Subject | 10 |
| Phased RF Study Procedure and Follow-up | Lost to Follow-up | 1 |
| Phased RF Study Procedure and Follow-up | Other reasons | 7 |
| Phased RF Study Procedure and Follow-up | Physician Decision | 3 |
| Phased RF Study Procedure and Follow-up | Protocol Violation | 1 |
| Phased RF Study Procedure and Follow-up | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Ablation |
|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 7.7 |
| Atrial fibrillation type long-term persistent atrial fibrillation | 21 Participants |
| Atrial fibrillation type persistent atrial fibrillation | 108 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 123 Participants |
| Region of Enrollment Canada | 10 participants |
| Region of Enrollment Hungary | 5 participants |
| Region of Enrollment Netherlands | 13 participants |
| Region of Enrollment United Kingdom | 7 participants |
| Region of Enrollment United States | 94 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 129 |
| other Total, other adverse events | 38 / 129 |
| serious Total, serious adverse events | 28 / 129 |
Outcome results
Primary
Number of Participants With Procedure and/or Device Related Stroke
A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee
Time frame: 30 days
Population: All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ablation | Number of Participants With Procedure and/or Device Related Stroke | 2 Participants |
Comparison: The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05p-value: 0.175exact binomial test
Secondary
6-month Post-procedure Effectiveness
For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG
Time frame: 6 months
Population: Of the 129 subjects with an index Phased RF ablation procedure, 114 were evaluable for the 6-month efficacy objective. There were 15 subjects that were not included in the 6-month efficacy objective; 13 due to study exit prior to the 6-month visit and 2 due to no 6-month ambulatory ECG
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ablation | 6-month Post-procedure Effectiveness | 60 Participants |
95% CI: [43.1, 62.1]
Secondary
Number of Participants With Acute Procedural Success
Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)
Time frame: 30 minutes
Population: All subjects who underwent a Phased RF study procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ablation | Number of Participants With Acute Procedural Success | 117 Participants |
Comparison: There was no prespecified hypothesis tested.95% CI: [84.3, 95.1]
Secondary
Number of Participants With Pulmonary Vein Stenosis
Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
Time frame: 3 months
Population: Number of subjects selected for participation in the pulmonary vein assessment cohort with baseline and 3-month evaluable magnetic resonance imaging scans of the pulmonary veins
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ablation | Number of Participants With Pulmonary Vein Stenosis | 0 Participants |
Comparison: There was no pre-specified hypothesis to test95% CI: [0, 6.1]