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Interventricular Delay of Lumax HF-T for Heart Failure

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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:
Biotronik, Inc.

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
Enrollment 122
Recruitment Details 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 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.
Arm/Group Title Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd
Hide Arm/Group Description Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days. Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
Period Title: First Treatment
Started 60 62
Completed 54 59
Not Completed 6 3
Reason Not Completed
Withdrawal by Subject             6             3
Period Title: Second Treatment
Started 54 59
Completed 52 59
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
Arm/Group Title Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total
Hide Arm/Group Description Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days. Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days. Total of all reporting groups
Overall Number of Baseline Participants 60 62 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  35.0%
27
  43.5%
48
  39.3%
>=65 years
39
  65.0%
35
  56.5%
74
  60.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 62 participants 122 participants
68.2  (14.1) 66.1  (12.0) 67.1  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
Female
16
  26.7%
10
  16.1%
26
  21.3%
Male
44
  73.3%
52
  83.9%
96
  78.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 62 participants 122 participants
United States 58 59 117
Switzerland 2 3 5
1.Primary Outcome
Title 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
Hide Description The purpose is to evaluate the effectiveness of optimized pacing (OPT) compared to simultaneous pacing (SIM). The hypothesis is evaluated based on a responder classification. Subjects are classified "not worsened" if after 30 days of OPT the quality of life (QOL) score is no more than 10 points higher and the six-minute walk distance is no more than 35 meters lower than after 30 days of SIM. The Minnesota Living with Heart Failure questionnaire, a 21 question patient-completed survey, was used for QOL. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105.
Time Frame 60 days after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study utilized an intention-to-treat analysis. 111 out of 122 enrolled subjects completed the primary endpoint follow-up. 106 of these subjects met analysis criteria based on paired quality of life and six-minute walk data at the one and two month visits. Subjects not included in analysis either withdrew consent or had incomplete study measures.
Arm/Group Title Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Hide Arm/Group Description:
Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
Total subjects enrolled in study.
Overall Number of Participants Analyzed 51 55 106
Measure Type: Number
Unit of Measure: Percent of Subjects
65 62 63
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Subjects
Comments

Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as "not worsened" after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.

An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as "not worsened" after changing from optimized to simultaneous biventricular pacing.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Non-inferiority comparison
Comments [Not Specified]
Method of Estimation Estimation Parameter Objective Performance Criteria
Estimated Value 63
Confidence Interval (1-Sided) 95%
54.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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
Hide Description The purpose of primary endpoint two is to evaluate adverse events that require additional invasive intervention to resolve, specifically those events that are directly related to the interventricular delay feature of the Lumax HF-T heart failure device. These adverse events include any software issues related to the programming of the interventricular delay or any event that occurs after optimization of the interventricular delay and that can be directly attributed to the use of the feature.
Time Frame 60 days after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Hide Arm/Group Description:
Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
Total subjects enrolled in study.
Overall Number of Participants Analyzed 60 62 122
Measure Type: Number
Unit of Measure: Percent of Subjects
100 100 100
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Subjects
Comments Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Non-inferiority comparison
Comments [Not Specified]
Method of Estimation Estimation Parameter Objective Performance Criteria
Estimated Value 100
Confidence Interval (1-Sided) 95%
97.6
Estimation Comments [Not Specified]
Time Frame Adverse event data was collected at each study visit until the final study visit at 6 months post enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Hide Arm/Group Description Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days. Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days. Total subjects enrolled in study.
All-Cause Mortality
Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/60 (5.00%)      5/62 (8.06%)      8/122 (6.56%)    
Cardiac disorders       
Atrial arrhythmia requring invasive intervention to resolve   1/60 (1.67%)  1 1/62 (1.61%)  1 2/122 (1.64%)  2
Ventricular arrhythmia requiring invasive intervention to resolve   0/60 (0.00%)  0 2/62 (3.23%)  2 2/122 (1.64%)  2
Non-heart failure cardiac symptoms requiring invasive intervention to resolve   1/60 (1.67%)  1 1/62 (1.61%)  1 2/122 (1.64%)  2
Other cardiac condition requiring invasive intervention to resolve   1/60 (1.67%)  1 3/62 (4.84%)  4 4/122 (3.28%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simultaneous 1st, Optimized 2nd Optimized 1st, Simultaneous 2nd Total Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/60 (11.67%)      14/62 (22.58%)      21/122 (17.21%)    
Cardiac disorders       
Worsening heart failure   4/60 (6.67%)  4 8/62 (12.90%)  9 12/122 (9.84%)  13
Other cardiac symptom   3/60 (5.00%)  3 7/62 (11.29%)  8 10/122 (8.20%)  11
Indicates events were collected by systematic assessment
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
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