Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
|Study Design:||Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|No text entered.|
|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.|
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
|Withdrawn due to study closure||337||338|
|Withdrawn prior to study closure||13||28|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|
|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.|
|CRT=ON||Cardiac Resynchronization Therapy activated.|
|CRT=OFF||Cardiac Resynchronization Therapy deactivated.|
|Total||Total of all reporting groups|
Number of Participants
Mean (Standard Deviation)
|57.6 (12.9)||58.3 (12.6)||58.0 (12.7)|
Region of Enrollment
|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 ]|
|4. Secondary:||NYHA Classification Change [ Time Frame: 6 months ]|
|5. Secondary:||Change in Quality of Life Scores From Baseline to 6-Month Follow-up [ Time Frame: 6 months ]|
|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 ]|
|7. Secondary:||Number of Subjects With All-cause Mortality [ Time Frame: Study duration from randomization to study exit ]|
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.|
|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:
Organization: Biotronik, Inc.
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