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Interventricular Delay of Lumax HF-T for Heart Failure

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.
ClinicalTrials.gov Identifier: NCT00508391
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : January 18, 2010
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Intervention: Device: Optimized interventricular delay biventricular pacing

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from each investigator's general patient population at the medical clinic and selected according to the study inclusion/exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled in the study were previously implanted with a Lumax HF-T heart failure device. The study utilized an intention-to-treat analysis where subjects were analyzed according to the randomized treatment order, regardless of whether they received the treatment in the order stipulated by the protocol.

Reporting Groups
  Description
Simultaneous 1st, Optimized 2nd Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
Optimized 1st, Simultaneous 2nd Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.

Participant Flow for 2 periods

Period 1:   First Treatment
    Simultaneous 1st, Optimized 2nd   Optimized 1st, Simultaneous 2nd
STARTED   60   62 
COMPLETED   54   59 
NOT COMPLETED   6   3 
Withdrawal by Subject                6                3 

Period 2:   Second Treatment
    Simultaneous 1st, Optimized 2nd   Optimized 1st, Simultaneous 2nd
STARTED   54   59 
COMPLETED   52   59 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 



  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.
No text entered.

Reporting Groups
  Description
Simultaneous 1st, Optimized 2nd Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
Optimized 1st, Simultaneous 2nd Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
Total Total of all reporting groups

Baseline Measures
   Simultaneous 1st, Optimized 2nd   Optimized 1st, Simultaneous 2nd   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   62   122 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   21   27   48 
>=65 years   39   35   74 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.2  (14.1)   66.1  (12.0)   67.1  (13.1) 
Gender 
[Units: Participants]
     
Female   16   10   26 
Male   44   52   96 
Region of Enrollment 
[Units: Participants]
     
United States   58   59   117 
Switzerland   2   3   5 


  Outcome Measures

1.  Primary:   Percentage of Subjects Classified as "Not Worsened" for Changes in the Minnesota Living With Heart Failure Questionnaire and Six-minute Walk Distance Between Periods of Optimized and Simultaneous Biventricular Pacing   [ Time Frame: 60 days after enrollment ]

2.  Primary:   Percent of Subjects That Did Not Experience an Adverse Event That Require Additional Invasive Intervention to Resolve, Specifically Related to the Interventricular Delay Feature of the Lumax HF-T Heart Failure Device   [ Time Frame: 60 days after enrollment ]


  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
No text entered.


  More Information

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: Clay Cohorn
Organization: BIOTRONIK, Inc.
phone: 503-387-2614
e-mail: clay.cohorn@biotronik.com



Responsible Party: Clay Cohorn, Clinical Studies Engineer II, Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00508391     History of Changes
Other Study ID Numbers: G070019
First Submitted: July 26, 2007
First Posted: July 30, 2007
Results First Submitted: October 27, 2009
Results First Posted: January 18, 2010
Last Update Posted: January 26, 2010