Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

This study has been terminated.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00683696
First received: August 30, 2007
Last updated: April 17, 2014
Last verified: April 2014
Results First Received: March 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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
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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
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Withdrawn due to study closure                 337                 338  
Withdrawn prior to study closure                 13                 28  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  
Number of Participants  
[units: participants]
  404     405     809  
Age  
[units: years]
Mean ± Standard Deviation
  57.6  ± 12.9     58.3  ± 12.6     58.0  ± 12.7  
Gender  
[units: participants]
     
Female     110     114     224  
Male     294     291     585  
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
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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 ]

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

3.  Secondary:   Rate of Worsening Heart Failure Hospitalization (Hospitalizations Per Subject-year)   [ Time Frame: Study duration from randomization to study exit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   NYHA Classification Change   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Quality of Life Scores From Baseline to 6-Month Follow-up   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life   [ Time Frame: Study duration from randomization to study exit for death, 24 months for hospitalization, 6 months for QOL evaluation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Number of Subjects With All-cause Mortality   [ Time Frame: Study duration from randomization to study exit ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame Study duration from date of implant to date of study exit, with a mean implant duration of 1.7 years
Additional Description Data for serious adverse event subcategories with an incidence of less than 3.0% are not shown. Patients could have more than one event. Other adverse event data includes data from non-serious adverse events.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    CRT=ON     CRT=OFF  
Total, other (not including serious) adverse events      
# participants affected / at risk     300/404     274/405  
Cardiac disorders      
Worsening heart failure      
# participants affected / at risk     29/404 (7.18%)     29/405 (7.16%)  
# events     32     34  
Atrial arrhythmia      
# participants affected / at risk     39/404 (9.65%)     35/405 (8.64%)  
# events     44     43  
Ventricular arrhythmia      
# participants affected / at risk     33/404 (8.17%)     25/405 (6.17%)  
# events     39     29  
Chest pain      
# participants affected / at risk     20/404 (4.95%)     29/405 (7.16%)  
# events     21     32  
Dyspnea      
# participants affected / at risk     20/404 (4.95%)     30/405 (7.41%)  
# events     27     32  
Hypotension      
# participants affected / at risk     27/404 (6.68%)     27/405 (6.67%)  
# events     28     30  
Dizziness      
# participants affected / at risk     21/404 (5.20%)     14/405 (3.46%)  
# events     25     15  
Edema      
# participants affected / at risk     21/404 (5.20%)     15/405 (3.70%)  
# events     23     16  
ICD lead      
# participants affected / at risk     28/404 (6.93%)     6/405 (1.48%)  
# events     34     6  
Lead for left ventricular pacing      
# participants affected / at risk     49/404 (12.13%)     10/405 (2.47%)  
# events     55     11  
General disorders      
Non-cardiovascular      
# participants affected / at risk     203/404 (50.25%)     201/405 (49.63%)  
# events     602     548  
Surgical and medical procedures      
Implant Procedure      
# participants affected / at risk     31/404 (7.67%)     41/405 (10.12%)  
# events     33     46  



  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
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


No publications provided by Biotronik, Inc.

Publications automatically indexed to this study:

Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00683696     History of Changes
Other Study ID Numbers: EchoCRT
Study First Received: August 30, 2007
Results First Received: March 12, 2014
Last Updated: April 17, 2014
Health Authority: United States: Food and Drug Administration