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Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) (EchoCRT)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00683696
First Posted: May 23, 2008
Last Update Posted: December 8, 2017
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.
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Biotronik, Inc.
Results First Submitted: March 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Ventricular Dyssynchrony
Intervention: Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

  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
After enrollment, baseline eligibility criteria were assessed (e.g. ventricular dyssynchrony, NYHA, QRS width, etc.) to qualify for implant. 1680 subjects were enrolled. 825 subjects did not qualify for implant and were exited from the study. 855 subjects qualified for implant. 821 subjects were successfully implanted. 809 subjects were randomized.

Reporting Groups
  Description
CRT=ON

Cardiac Resynchronization Therapy activated.

Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=ON.

CRT=OFF

Cardiac Resynchronization Therapy deactivated.

Subject implanted with BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled and randomized to CRT=OFF.


Participant Flow:   Overall Study
    CRT=ON   CRT=OFF
STARTED   404   405 
COMPLETED   0   0 
NOT COMPLETED   404   405 
Withdrawn due to study closure                337                338 
Withdrawn prior to study closure                13                28 
Lost to Follow-up                5                6 
Vital status follow-up only                3                3 
Death                46                30 



  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.
Baseline characterisics were analzed for the randomized population.

Reporting Groups
  Description
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.
Total Total of all reporting groups

Baseline Measures
   CRT=ON   CRT=OFF   Total 
Overall Participants Analyzed 
[Units: Participants]
 404   405   809 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (12.9)   58.3  (12.6)   58.0  (12.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      110  27.2%      114  28.1%      224  27.7% 
Male      294  72.8%      291  71.9%      585  72.3% 
Region of Enrollment 
[Units: Participants]
     
Portugal   4   3   7 
United States   196   198   394 
Spain   18   18   36 
Austria   6   8   14 
Israel   18   16   34 
United Kingdom   19   18   37 
Switzerland   11   11   22 
Italy   4   4   8 
France   10   11   21 
Czech Republic   12   11   23 
Canada   13   14   27 
Poland   0   2   2 
Belgium   6   6   12 
Australia   12   11   23 
Denmark   24   23   47 
Germany   41   41   82 
Netherlands   10   10   20 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death   [ Time Frame: From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years ]

Measure Type Primary
Measure Title Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
Measure Description The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.
Time Frame From date of randomization until date of death from any cause or date of first hospitalization for worsening heart failure, whichever came first, assessed up to date of study exit, with a mean treatment duration of 1.6 years  

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.
This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.

Reporting Groups
  Description
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 404   405 
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death 
[Units: Participants]
 116   102 

No statistical analysis provided for Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death



2.  Primary:   Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
Measure Description The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
Time Frame 6 months  

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 primary safety endpoint included all subjects undergoing an implant procedure.

Reporting Groups
  Description
Subjects That Underwent an Implant Attempt No text entered.

Measured Values
   Subjects That Underwent an Implant Attempt 
Participants Analyzed 
[Units: Participants]
 855 
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free) 
[Units: Participants]
 766 

No statistical analysis provided for Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)



3.  Secondary:   Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)   [ Time Frame: Study duration from randomization to study exit ]

Measure Type Secondary
Measure Title Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Measure Description Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
Time Frame Study duration from randomization to study exit  

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
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 404   405 
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year) 
[Units: Hospitalizations per subj-yr]
 0.36   0.28 

No statistical analysis provided for Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)



4.  Secondary:   New York Heart Association (NYHA) Classification Change   [ Time Frame: 6 months ]

Measure Type Secondary
Measure Title New York Heart Association (NYHA) Classification Change
Measure Description

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.

NYHA classes:

Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.

Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 6 months  

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 Baseline & 6-month NYHA classification. 18 subjects (9 CRT ON, 9 CRT OFF) that were in the study at least 6 months and that did not have 6-month NYHA data, had the most recent post-randomization NYHA inputted using the Last Observation Carried Forward (LOCF) principle.

Reporting Groups
  Description
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 347   338 
New York Heart Association (NYHA) Classification Change 
[Units: Participants]
Count of Participants
   
Improved at least 1 Class   213   185 
No Change   116   141 
Deteriorated at least 1 Class   18   12 

No statistical analysis provided for New York Heart Association (NYHA) Classification Change



5.  Secondary:   Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up   [ Time Frame: Changes between baseline and 6 months ]

Measure Type Secondary
Measure Title Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Measure Description Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.
Time Frame Changes between baseline and 6 months  

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 Baseline & 6-month QOL scores. 25 subjects (15 CRT ON, 10 CRT OFF) that were in the study at least 6 months and that did not have 6-month QOL data, had 3-month data inputted using the LOCF principle.

Reporting Groups
  Description
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 333   330 
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up 
[Units: Units on a scale]
Mean (Standard Deviation)
 -12.1  (21.9)   -13.5  (21.4) 

No statistical analysis provided for Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up



6.  Secondary:   Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)   [ Time Frame: Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months) ]

Measure Type Secondary
Measure Title Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Measure Description

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.

This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)

Composite Endpoint Scoring:

Vital Status:

Death (-3),

Survival to end of trial (0),

Hospitalization:

1st hospitalization for HF (-1),

No hospitalization (0),

QOL score:*

Improvement by ≥ 10 units (+2),

Improvement by 5-9 units (+1),

Change by < 5 units (0),

Worsening by 5-9 units (-1),

Worsening by ≥ 10 (-2).

Possible total score -6 to +2.

*QOL score details are provided in Secondary Outcome Measure 5.

Time Frame Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)  

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 a potential of 24 months of follow-up.

Reporting Groups
  Description
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 163   163 
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL) 
[Units: Composite score]
Mean (Standard Deviation)
 -1.6  (1.9)   -1.5  (1.6) 

No statistical analysis provided for Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)



7.  Secondary:   Number of Subjects With All-cause Mortality   [ Time Frame: From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years ]

Measure Type Secondary
Measure Title Number of Subjects With All-cause Mortality
Measure Description Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Time Frame From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years  

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
CRT=ON Cardiac Resynchronization Therapy activated.
CRT=OFF Cardiac Resynchronization Therapy deactivated.

Measured Values
   CRT=ON   CRT=OFF 
Participants Analyzed 
[Units: Participants]
 404   405 
Number of Subjects With All-cause Mortality 
[Units: Participants]
Count of Participants
 45   26 

No statistical analysis provided for Number of Subjects With All-cause Mortality




  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
Endpoint results should be interpreted with caution and take into consideration the early study closure and subsequent reduction in sample size (809 vs. 1258) and events (218 vs. 381). These changes impact the statistical power of the findings.


  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: Kelly Mohr
Organization: Biotronik, Inc.
phone: 800-547-0394
e-mail: kelly.mohr@biotronik.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00683696     History of Changes
Other Study ID Numbers: EchoCRT
First Submitted: August 30, 2007
First Posted: May 23, 2008
Results First Submitted: March 12, 2014
Results First Posted: April 17, 2014
Last Update Posted: December 8, 2017