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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.
ClinicalTrials.gov Identifier: NCT00683696
Recruitment Status : Terminated
First Posted : May 23, 2008
Results First Posted : April 17, 2014
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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Withdrawn due to study closure                337                338 
Withdrawn prior to study closure                13                28 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

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

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

Time Frame Study duration from date of implant to date of study exit, with a mean implant duration of 1.7 years
Additional Description Subjects could have more than one event. Other adverse event data includes data from non-serious adverse events.

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

Serious Adverse Events
    CRT=ON   CRT=OFF
Total, All-Cause Mortality     
# participants affected / at risk   45/404 (11.14%)   26/405 (6.42%) 
Total, Serious Adverse Events     
# participants affected / at risk   259/404 (64.11%)   221/405 (54.57%) 
Cardiac disorders     
Worsening heart failure     
# participants affected / at risk   101/404 (25.00%)   93/405 (22.96%) 
# events   213   181 
Atrial arrhythmia     
# participants affected / at risk   27/404 (6.68%)   25/405 (6.17%) 
# events   34   35 
Ventricular arrhythmia     
# participants affected / at risk   26/404 (6.44%)   22/405 (5.43%) 
# events   36   29 
Chest pain     
# participants affected / at risk   16/404 (3.96%)   21/405 (5.19%) 
# events   31   26 
Other cardiovascular     
# participants affected / at risk   18/404 (4.46%)   17/405 (4.20%) 
# events   21   20 
Dyspnea     
# participants affected / at risk   16/404 (3.96%)   11/405 (2.72%) 
# events   16   12 
Coronary artery disease     
# participants affected / at risk   13/404 (3.22%)   10/405 (2.47%) 
# events   13   11 
ICD lead     
# participants affected / at risk   23/404 (5.69%)   13/405 (3.21%) 
# events   26   13 
Lead for right atrial pacing     
# participants affected / at risk   18/404 (4.46%)   5/405 (1.23%) 
# events   21   5 
Lead for left ventricular pacing     
# participants affected / at risk   18/404 (4.46%)   4/405 (0.99%) 
# events   21   4 
Hypotension     
# participants affected / at risk   11/404 (2.72%)   9/405 (2.22%) 
# events   14   9 
Angina     
# participants affected / at risk   7/404 (1.73%)   12/405 (2.96%) 
# events   8   13 
Peripheral vascular disease     
# participants affected / at risk   6/404 (1.49%)   10/405 (2.47%) 
# events   8   12 
Syncope     
# participants affected / at risk   8/404 (1.98%)   7/405 (1.73%) 
# events   8   9 
Cardiac arrest     
# participants affected / at risk   11/404 (2.72%)   3/405 (0.74%) 
# events   13   3 
Myocardial infarction     
# participants affected / at risk   6/404 (1.49%)   6/405 (1.48%) 
# events   6   8 
Anemia     
# participants affected / at risk   5/404 (1.24%)   4/405 (0.99%) 
# events   9   4 
Stroke     
# participants affected / at risk   6/404 (1.49%)   6/405 (1.48%) 
# events   7   6 
Pulmonary embolism     
# participants affected / at risk   5/404 (1.24%)   5/405 (1.23%) 
# events   5   7 
Transischemic attack     
# participants affected / at risk   6/404 (1.49%)   4/405 (0.99%) 
# events   6   4 
Thrombosis     
# participants affected / at risk   3/404 (0.74%)   5/405 (1.23%) 
# events   3   6 
Fluid accumulation     
# participants affected / at risk   5/404 (1.24%)   1/405 (0.25%) 
# events   7   1 
Pulmonary edema     
# participants affected / at risk   5/404 (1.24%)   2/405 (0.49%) 
# events   5   3 
Cardiac catheterization     
# participants affected / at risk   5/404 (1.24%)   2/405 (0.49%) 
# events   5   2 
Cardiovascular medication related     
# participants affected / at risk   3/404 (0.74%)   4/405 (0.99%) 
# events   3   4 
Dizziness     
# participants affected / at risk   4/404 (0.99%)   3/405 (0.74%) 
# events   4   3 
Pleural effusion     
# participants affected / at risk   4/404 (0.99%)   2/405 (0.49%) 
# events   4   2 
Valvular heart disease     
# participants affected / at risk   4/404 (0.99%)   1/405 (0.25%) 
# events   5   1 
Abdominal Aortic Aneurysm     
# participants affected / at risk   3/404 (0.74%)   2/405 (0.49%) 
# events   3   2 
Edema     
# participants affected / at risk   1/404 (0.25%)   3/405 (0.74%) 
# events   1   3 
Increased INR     
# participants affected / at risk   2/404 (0.50%)   1/405 (0.25%) 
# events   3   1 
Palpitations     
# participants affected / at risk   1/404 (0.25%)   2/405 (0.49%) 
# events   1   2 
Bradycardia     
# participants affected / at risk   1/404 (0.25%)   1/405 (0.25%) 
# events   1   1 
Dilated cardiomyopathy     
# participants affected / at risk   1/404 (0.25%)   1/405 (0.25%) 
# events   1   1 
Hypertension     
# participants affected / at risk   1/404 (0.25%)   1/405 (0.25%) 
# events   1   1 
Ischemic cardiomyopathy     
# participants affected / at risk   1/404 (0.25%)   1/405 (0.25%) 
# events   1   1 
Weight gain     
# participants affected / at risk   2/404 (0.50%)   0/405 (0.00%) 
# events   2   0 
Fatigue     
# participants affected / at risk   1/404 (0.25%)   0/405 (0.00%) 
# events   1   0 
Device related     
# participants affected / at risk   6/404 (1.49%)   9/405 (2.22%) 
# events   6   10 
Endocrine disorders     
Endocrine     
# participants affected / at risk   12/404 (2.97%)   4/405 (0.99%) 
# events   13   6 
Gastrointestinal disorders     
Gastrointestinal disorder     
# participants affected / at risk   43/404 (10.64%)   28/405 (6.91%) 
# events   68   41 
General disorders     
Other noncardiovascular     
# participants affected / at risk   40/404 (9.90%)   36/405 (8.89%) 
# events   54   55 
Cancer     
# participants affected / at risk   5/404 (1.24%)   10/405 (2.47%) 
# events   5   13 
Traumatic injury     
# participants affected / at risk   11/404 (2.72%)   4/405 (0.99%) 
# events   12   4 
Fatigue     
# participants affected / at risk   3/404 (0.74%)   0/405 (0.00%) 
# events   3   0 
Hepatobiliary disorders     
Hepatic     
# participants affected / at risk   1/404 (0.25%)   2/405 (0.49%) 
# events   2   2 
Infections and infestations     
Infection     
# participants affected / at risk   58/404 (14.36%)   45/405 (11.11%) 
# events   77   54 
Musculoskeletal and connective tissue disorders     
Musculoskeletal disorder     
# participants affected / at risk   25/404 (6.19%)   15/405 (3.70%) 
# events   32   18 
Nervous system disorders     
Nervous system disorder     
# participants affected / at risk   13/404 (3.22%)   5/405 (1.23%) 
# events   16   5 
Headache     
# participants affected / at risk   0/404 (0.00%)   3/405 (0.74%) 
# events   0   4 
Renal and urinary disorders     
Renal disorder     
# participants affected / at risk   28/404 (6.93%)   16/405 (3.95%) 
# events   38   19 
Respiratory, thoracic and mediastinal disorders     
Respiratory disorder     
# participants affected / at risk   14/404 (3.47%)   22/405 (5.43%) 
# events   27   38 
Surgical and medical procedures     
Implantation related     
# participants affected / at risk   17/404 (4.21%)   16/405 (3.95%) 
# events   19   18 




  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
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: January 17, 2018