Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) (EchoCRT)

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. Identifier: NCT00683696
Recruitment Status : Terminated
First Posted : May 23, 2008
Results First Posted : April 17, 2014
Last Update Posted : January 17, 2018
University of Zurich
Information provided by (Responsible Party):
Biotronik, Inc.

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

  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.
Baseline characterisics were analzed for the randomized population.

Reporting Groups
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 
[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

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

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

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

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) ]

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 ]

  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
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

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

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

Responsible Party: Biotronik, Inc. 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: January 17, 2018