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Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

This study has been terminated.
(Lower enrollment rate than expected)
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01520714
First received: February 22, 2010
Last updated: April 30, 2014
Last verified: April 2014
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Congestive Heart Failure
Intervention: Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients required at physician office. Recruiting will be active until 40 patients are randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Medtronic Passive Fixation LV Lead

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Medtronic 4195 Active Fixation LV Lead

Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.


Participant Flow:   Overall Study
    Medtronic Passive Fixation LV Lead     Medtronic 4195 Active Fixation LV Lead  
STARTED     0     11  
COMPLETED     0     5  
NOT COMPLETED     0     6  
Protocol Violation                 0                 3  
Adverse Event                 0                 2  
Lack of Efficacy                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Medtronic Passive Fixation LV Lead

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Medtronic 4195 Active Fixation LV Lead

Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule

Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.

Total Total of all reporting groups

Baseline Measures
    Medtronic Passive Fixation LV Lead     Medtronic 4195 Active Fixation LV Lead     Total  
Number of Participants  
[units: participants]
  0     11     11  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         7     7  
>=65 years         4     4  
Age  
[units: years]
Mean ± Standard Deviation
      65  ± 11     65  ± 11  
Gender  
[units: participants]
     
Female         1     1  
Male         10     10  
Region of Enrollment  
[units: participants]
     
United States         11     11  



  Outcome Measures

1.  Primary:   Evidence of Change in Threshold of >1 Volt With Posture Changes   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Research Manager
Organization: The Heart Hospital Baylor Plano
phone: 469-814-4712
e-mail: natalie.settele@baylorhealth.edu


No publications provided


Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01520714     History of Changes
Other Study ID Numbers: 009-067
Study First Received: February 22, 2010
Results First Received: August 9, 2013
Last Updated: April 30, 2014
Health Authority: United States: Institutional Review Board