Trial Outcomes & Findings for Evaluation of the Phased Radio Frequency Ablation System (NCT NCT01693120)
NCT ID: NCT01693120
Last Updated: 2025-02-13
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
199 participants
Primary outcome timeframe
30 days
Results posted on
2025-02-13
Participant Flow
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.
Participant milestones
| Measure |
Ablation
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Enrollment
STARTED
|
199
|
|
Enrollment
COMPLETED
|
129
|
|
Enrollment
NOT COMPLETED
|
70
|
|
Phased RF Study Procedure and Follow-up
STARTED
|
129
|
|
Phased RF Study Procedure and Follow-up
COMPLETED
|
112
|
|
Phased RF Study Procedure and Follow-up
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Ablation
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Enrollment
Lost to Follow-up
|
1
|
|
Enrollment
Withdrawal by Subject
|
10
|
|
Enrollment
Protocol Violation
|
46
|
|
Enrollment
Physician Decision
|
3
|
|
Enrollment
Adverse Event
|
1
|
|
Enrollment
Study closed
|
8
|
|
Enrollment
Other
|
1
|
|
Phased RF Study Procedure and Follow-up
Lost to Follow-up
|
1
|
|
Phased RF Study Procedure and Follow-up
Withdrawal by Subject
|
5
|
|
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
Other reasons
|
7
|
Baseline Characteristics
Evaluation of the Phased Radio Frequency Ablation System
Baseline characteristics by cohort
| Measure |
Ablation
n=129 Participants
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
|
Atrial fibrillation type
persistent atrial fibrillation
|
108 Participants
n=5 Participants
|
|
Atrial fibrillation type
long-term persistent atrial fibrillation
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium
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
Outcome measures
| Measure |
Ablation
n=127 Participants
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Number of Participants With Procedure and/or Device Related Stroke
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
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
Outcome measures
| Measure |
Ablation
n=114 Participants
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
6-month Post-procedure Effectiveness
|
60 Participants
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: All subjects who underwent a Phased RF study procedure
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)
Outcome measures
| Measure |
Ablation
n=129 Participants
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Number of Participants With Acute Procedural Success
|
117 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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
Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure
Outcome measures
| Measure |
Ablation
n=59 Participants
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Number of Participants With Pulmonary Vein Stenosis
|
0 Participants
|
Adverse Events
Ablation
Serious events: 28 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ablation
n=129 participants at risk
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
2/129 • Number of events 2 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Atrial flutter
|
3.9%
5/129 • Number of events 5 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Bradycardia
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Cardiac failure congestive
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Chronotropic incompetence
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Coronary artery stenosis
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Pericardial effusion
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Cardiac disorders
Pericarditis
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
General disorders
Non-cardiac chest pain
|
1.6%
2/129 • Number of events 2 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Infections and infestations
Tracheobronchitis
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Infections and infestations
Urosepsis
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.3%
3/129 • Number of events 3 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Investigations
Blood creatinine increased
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Nervous system disorders
Cerebrovascular accident
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Vascular disorders
Haematoma
|
1.6%
2/129 • Number of events 2 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Vascular disorders
Hypotension
|
0.78%
1/129 • Number of events 1 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
Other adverse events
| Measure |
Ablation
n=129 participants at risk
Phased RF ablation
Medtronic Phased RF Ablation System: Phased RF ablation
|
|---|---|
|
Eye disorders
Visual impairment
|
3.1%
4/129 • Number of events 4 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
General disorders
Chest discomfort
|
3.1%
4/129 • Number of events 4 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
General disorders
Chest pain
|
3.1%
4/129 • Number of events 5 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
General disorders
Oedema peripheral
|
3.9%
5/129 • Number of events 5 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Infections and infestations
Influenza
|
3.1%
4/129 • Number of events 4 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
3.9%
5/129 • Number of events 5 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Nervous system disorders
Dizziness
|
4.7%
6/129 • Number of events 6 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Nervous system disorders
Headache
|
7.8%
10/129 • Number of events 10 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
|
Renal and urinary disorders
Haematuria
|
3.1%
4/129 • Number of events 4 • All adverse events were collected between subject consent and study completion (6-months post Phased RF study ablation procedure) or study exit
|
Additional Information
Bob Hokanson, Clinical Research Manager
Medtronic AF Solutions
Phone: 763.526.2811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER