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

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

Cardiac Resynchronization Therapy activated.

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


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
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Withdrawn due to study closure                337                338 
Withdrawn prior to study closure                13                28 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

  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