We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Attain Performa
Previous Study | Return to List | Next Study

Attain Performa(TM) Quadripolar Lead Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751022
First Posted: December 17, 2012
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
Results First Submitted: February 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Out of the 1202 Intial enrollments; 77 were excluded due to to the following pre-implant events:

  1. unsuccessful cannulation (25)
  2. death (3)
  3. Exit prior to implant attempt (43)
  4. Attain Performa Lead implant not attempted (6)

Resulting in 1125 subjects with Attain Performa Lead Implant Attempts


Reporting Groups
  Description
Model 4298 Patients with an implant attempt for the Attain Performa Lead Model 4298
Model 4398 Patients with an implant attempt for the Attain Performa Lead Model 4398
Model 4598 Patients with an implant attempt for the Attain Performa Lead Model 4598

Participant Flow:   Overall Study
    Model 4298   Model 4398   Model 4598
STARTED   499   326   300 
COMPLETED   443 [1]   282 [1]   273 [1] 
NOT COMPLETED   56   44   27 
[1] 6 month visit



  Baseline Characteristics
  Hide 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.
Subjects with an attempted Attain Performa LV Lead implant

Reporting Groups
  Description
Attain Performa LV Lead Model 4298 Subjects with an attempted Attain Performa LV Lead Model 4298 implant
Attain Performa LV Lead Model 4398 Subjects with an attempted Attain Performa LV Lead Model 4398 implant
Attain Performa LV Lead Model 4598 Subjects with an attempted Attain Performa LV Lead Model 4598 implant
Total Total of all reporting groups

Baseline Measures
   Attain Performa LV Lead Model 4298   Attain Performa LV Lead Model 4398   Attain Performa LV Lead Model 4598   Total 
Overall Participants Analyzed 
[Units: Participants]
 499   326   300   1125 
Age 
[Units: Years]
Mean (Standard Deviation)
 68  (11)   66  (11)   67  (11)   67  (11) 
Gender 
[Units: Participants]
       
Female   143   93   93   329 
Male   356   233   207   796 
Race/Ethnicity, Customized 
[Units: Participants]
       
Subject/physician chose not to provide information   14   9   5   28 
Not reportable per local laws or regulations   30   21   48   99 
American Indian or Alaska Native   4   0   5   9 
Asian   7   8   17   32 
Black or African American   38   21   17   76 
Hispanic or Latino   18   11   11   40 
Native Hawaiian or Pacific Islander   0   1   0   1 
White or Caucasian   387   252   197   836 
Two or more races   1   3   0   4 
Region of Enrollment 
[Units: Participants]
       
United States   360   249   152   761 
Malaysia   0   1   1   2 
Greece   0   1   0   1 
Saudi Arabia   9   6   2   17 
Austria   8   0   2   10 
Netherlands   13   1   9   23 
Slovakia   4   2   7   13 
Slovenia   0   5   3   8 
Chile   12   0   0   12 
France   0   2   8   10 
Serbia   0   2   8   10 
Romania   11   0   1   12 
Hungary   0   3   4   7 
United Kingdom   13   4   14   31 
Switzerland   2   1   1   4 
India   3   3   15   21 
Spain   3   1   0   4 
Canada   17   22   21   60 
Belgium   3   1   5   9 
Norway   5   0   0   5 
Finland   0   3   1   4 
Denmark   1   1   8   10 
Italy   8   10   10   28 
South Africa   3   2   2   7 
Israel   0   2   2   4 
Australia   17   1   5   23 
Germany   7   3   19   29 
New York Heart Association Classification (NYHA) [1] 
[Units: Participants]
       
 8   4   4   16 
II   125   94   89   308 
III   352   216   198   766 
IV   14   12   9   35 
[1] NYHA Functional Classification is assessed as following. Class I: No limitation of physical activity. Class II:Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. For more details see American Heart Association website http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp#.V_5rPPkrJD8
Left Ventricular Ejection Fraction (LVEF) 
[Units: %]
Mean (Standard Deviation)
 25  (7)   26  (7)   27  (7)   26  (7) 
QRS (Electrocardiogram Complex) 
[Units: Ms]
Mean (Standard Deviation)
 155  (23)   156  (24)   156  (23)   156  (23) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Lead Complication-free Rate at 6 Months   [ Time Frame: Implant to 6 months post-implant ]

2.  Primary:   LV Pacing Capture Thresholds Per Attain Performa Lead Model   [ Time Frame: 6 months post-implant ]

3.  Secondary:   Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities   [ Time Frame: 6 months post-implant ]

4.  Secondary:   Percentage of Subjects With Successful Implant Per Attain Performa Lead Model   [ Time Frame: Implant up to 1-month post implant ]

5.  Secondary:   Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model   [ Time Frame: Implant up to 1-month post implant ]

6.  Secondary:   Pacing Capture Thresholds at the Final Programmed Pacing Polarity   [ Time Frame: 6 months post-implant ]

7.  Secondary:   Implant Related Times Per Attain Performa Lead Model   [ Time Frame: Implant up to 1-month post implant ]

8.  Secondary:   Pacing Impedance at the Final Programmed Pacing Polarity   [ Time Frame: 6 month post-implant ]

9.  Secondary:   Complication Rate for Individual Attain Performa Lead Related Events   [ Time Frame: 6 month post-Implant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Shelby Li
Organization: Medtronic
phone: +17635262704
e-mail: shelby.li@medtronic.com



Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01751022     History of Changes
Other Study ID Numbers: Attain Performa(TM)
First Submitted: December 3, 2012
First Posted: December 17, 2012
Results First Submitted: February 29, 2016
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016