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Evaluation of the Phased Radio Frequency Ablation System (VICTORY-AF)

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ClinicalTrials.gov Identifier: NCT01693120
Recruitment Status : Terminated (The study was stopped solely based on lower than expected enrollment rate.)
First Posted : September 26, 2012
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Persistent Atrial Fibrillation
Intervention: Device: Medtronic Phased RF Ablation System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ablation

Phased RF ablation

Medtronic Phased RF Ablation System: Phased RF ablation


Participant Flow for 2 periods

Period 1:   Enrollment
    Ablation
STARTED   199 [1] 
COMPLETED   129 [2] 
NOT COMPLETED   70 
Lost to Follow-up                1 
Withdrawal by Subject                10 
Protocol Violation                46 
Physician Decision                3 
Adverse Event                1 
Study closed                8 
Not specified                1 
[1] 70 subjects exited the study after consent, but prior to undergoing a study ablation procedure.
[2] 129 of the 199 enrolled subjects underwent a Phased RF study procedure

Period 2:   Phased RF Study Procedure and Follow-up
    Ablation
STARTED   129 
COMPLETED   112 [1] 
NOT COMPLETED   17 
Lost to Follow-up                1 
Withdrawal by Subject                5 
Physician Decision                3 
Protocol Violation                1 
Other reasons                7 
[1] 112 of the 129 subjects with a Phased RF procedure completed the 6-month follow-up visit



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline analysis population is the number of subjects that had an ablation attempt with the Phased RF system.

Reporting Groups
  Description
Ablation

Phased RF ablation

Medtronic Phased RF Ablation System: Phased RF ablation


Baseline Measures
   Ablation 
Overall Participants Analyzed 
[Units: Participants]
 129 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.6  (7.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26  20.2% 
Male      103  79.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      123  95.3% 
More than one race      0   0.0% 
Unknown or Not Reported      4   3.1% 
Region of Enrollment 
[Units: Participants]
 
Canada   10 
Netherlands   13 
Hungary   5 
United States   94 
United Kingdom   7 
Atrial fibrillation type 
[Units: Participants]
Count of Participants
 
persistent atrial fibrillation      108  83.7% 
long-term persistent atrial fibrillation      21  16.3% 


  Outcome Measures

1.  Primary:   Number of Participants With Procedure and/or Device Related Stroke   [ Time Frame: 30 days ]

2.  Secondary:   6-month Post-procedure Effectiveness   [ Time Frame: 6 months ]

3.  Secondary:   Number of Participants With Acute Procedural Success   [ Time Frame: 30 minutes ]

4.  Secondary:   Number of Participants With Pulmonary Vein Stenosis   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study stopped enrolling prematurely due to slow enrollment. Since the achieved sample size is 57% smaller than the planned sample size of 300 evaluable subjects, the study objectives could not be properly evaluated.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bob Hokanson, Clinical Research Manager
Organization: Medtronic AF Solutions
phone: 763.526.2811
e-mail: robert.hokanson@medtronic.com



Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01693120     History of Changes
Other Study ID Numbers: VICTORY AF
First Submitted: September 19, 2012
First Posted: September 26, 2012
Results First Submitted: February 7, 2018
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018