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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:
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)
Enrollment 1680
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 404 405
Completed 0 0
Not Completed 404 405
Reason Not Completed
Withdrawn due to study closure             337             338
Withdrawn prior to study closure             13             28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
Arm/Group Title CRT=ON CRT=OFF Total
Hide Arm/Group Description Cardiac Resynchronization Therapy activated. Cardiac Resynchronization Therapy deactivated. Total of all reporting groups
Overall Number of Baseline Participants 404 405 809
Hide Baseline Analysis Population Description
Baseline characterisics were analzed for the randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 404 participants 405 participants 809 participants
57.6  (12.9) 58.3  (12.6) 58.0  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 404 participants 405 participants 809 participants
Female
110
  27.2%
114
  28.1%
224
  27.7%
Male
294
  72.8%
291
  71.9%
585
  72.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 404 participants 405 participants 809 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
1.Primary Outcome
Title Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
Hide Description The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure.
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
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was carried out according to the intention-to-treat principle. Follow-up was censored at study closure, date of death, LVAD, heart transplant, withdrawal from the study, or loss to follow-up, whichever came first. 4 deaths in CRT OFF group and 1 death in CRT ON group were after LVAD/transplant and are not included in this analysis.
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 404 405
Measure Type: Number
Unit of Measure: participants
116 102
2.Primary Outcome
Title Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
Hide Description The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The primary safety endpoint included all subjects undergoing an implant procedure.
Arm/Group Title Subjects That Underwent an Implant Attempt
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 855
Measure Type: Number
Unit of Measure: participants
766
3.Secondary Outcome
Title Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Hide Description Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
Time Frame Study duration from randomization to study exit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 404 405
Measure Type: Number
Unit of Measure: Hospitalizations per subj-yr
0.36 0.28
4.Secondary Outcome
Title New York Heart Association (NYHA) Classification Change
Hide Description

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.

NYHA classes:

Class I - Subjects with cardiac disease, but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation,dyspnea, or anginal pain.

Class II - Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III - Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV - Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Baseline & 6-month NYHA classification. 18 subjects (9 CRT ON, 9 CRT OFF) that were in the study at least 6 months and that did not have 6-month NYHA data, had the most recent post-randomization NYHA inputted using the Last Observation Carried Forward (LOCF) principle.
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 347 338
Measure Type: Count of Participants
Unit of Measure: Participants
Improved at least 1 Class
213
  61.4%
185
  54.7%
No Change
116
  33.4%
141
  41.7%
Deteriorated at least 1 Class
18
   5.2%
12
   3.6%
5.Secondary Outcome
Title Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Hide Description Quality of Life was evaluated using the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.The questionnaire consists of 21 questions to measure the subjects' perception of how their HF and its treatment affected their ability to live as they wanted during the last month. The questions describe different ways in which some people are affected (i.e. physical, socioeconomic, and psychological impairments). If a question does not apply to a subject or is not related to their HF, then they can answer with a 0. If it does apply to them, then they can rate (from 1 to 5) how much it has affected them. From the 21 questions, the lowest possible total score is 0, and the highest possible total score is 105. A lower score is desirable. Therefore, a negative change in QOL score from baseline to 6 months represents an improvement in quality of life, while a positive change in QOL score from baseline to 6 months represents a worsening in quality of life.
Time Frame Changes between baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with Baseline & 6-month QOL scores. 25 subjects (15 CRT ON, 10 CRT OFF) that were in the study at least 6 months and that did not have 6-month QOL data, had 3-month data inputted using the LOCF principle.
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 333 330
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.1  (21.9) -13.5  (21.4)
6.Secondary Outcome
Title Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Hide Description

Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.

This composite endpoint used a weighted scoring scale based on the African-American Heart Failure Trial (A-HeFT) study Endpoint Score. (Taylor, AL, Ziesche, S, Yancy, C, et al. Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure. N Engl J Med 2004; 351:2049-57.)

Composite Endpoint Scoring:

Vital Status:

Death (-3),

Survival to end of trial (0),

Hospitalization:

1st hospitalization for HF (-1),

No hospitalization (0),

QOL score:*

Improvement by ≥ 10 units (+2),

Improvement by 5-9 units (+1),

Change by < 5 units (0),

Worsening by 5-9 units (-1),

Worsening by ≥ 10 (-2).

Possible total score -6 to +2.

*QOL score details are provided in Secondary Outcome Measure 5.

Time Frame Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with a potential of 24 months of follow-up.
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 163 163
Mean (Standard Deviation)
Unit of Measure: Composite score
-1.6  (1.9) -1.5  (1.6)
7.Secondary Outcome
Title Number of Subjects With All-cause Mortality
Hide Description Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Time Frame From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description:
Cardiac Resynchronization Therapy activated.
Cardiac Resynchronization Therapy deactivated.
Overall Number of Participants Analyzed 404 405
Measure Type: Count of Participants
Unit of Measure: Participants
45
  11.1%
26
   6.4%
Time Frame Study duration from date of implant to date of study exit, with a mean implant duration of 1.7 years
Adverse Event Reporting Description Subjects could have more than one event. Other adverse event data includes data from non-serious adverse events.
 
Arm/Group Title CRT=ON CRT=OFF
Hide Arm/Group Description Cardiac Resynchronization Therapy activated. Cardiac Resynchronization Therapy deactivated.
All-Cause Mortality
CRT=ON CRT=OFF
Affected / at Risk (%) Affected / at Risk (%)
Total   45/404 (11.14%)      26/405 (6.42%)    
Show Serious Adverse Events Hide Serious Adverse Events
CRT=ON CRT=OFF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   259/404 (64.11%)      221/405 (54.57%)    
Cardiac disorders     
Worsening heart failure  101/404 (25.00%)  213 93/405 (22.96%)  181
Atrial arrhythmia  27/404 (6.68%)  34 25/405 (6.17%)  35
Ventricular arrhythmia  26/404 (6.44%)  36 22/405 (5.43%)  29
Chest pain  16/404 (3.96%)  31 21/405 (5.19%)  26
Other cardiovascular  18/404 (4.46%)  21 17/405 (4.20%)  20
Dyspnea  16/404 (3.96%)  16 11/405 (2.72%)  12
Coronary artery disease  13/404 (3.22%)  13 10/405 (2.47%)  11
ICD lead  23/404 (5.69%)  26 13/405 (3.21%)  13
Lead for right atrial pacing  18/404 (4.46%)  21 5/405 (1.23%)  5
Lead for left ventricular pacing  18/404 (4.46%)  21 4/405 (0.99%)  4
Hypotension  11/404 (2.72%)  14 9/405 (2.22%)  9
Angina  7/404 (1.73%)  8 12/405 (2.96%)  13
Peripheral vascular disease  6/404 (1.49%)  8 10/405 (2.47%)  12
Syncope  8/404 (1.98%)  8 7/405 (1.73%)  9
Cardiac arrest  11/404 (2.72%)  13 3/405 (0.74%)  3
Myocardial infarction  6/404 (1.49%)  6 6/405 (1.48%)  8
Anemia  5/404 (1.24%)  9 4/405 (0.99%)  4
Stroke  6/404 (1.49%)  7 6/405 (1.48%)  6
Pulmonary embolism  5/404 (1.24%)  5 5/405 (1.23%)  7
Transischemic attack  6/404 (1.49%)  6 4/405 (0.99%)  4
Thrombosis  3/404 (0.74%)  3 5/405 (1.23%)  6
Fluid accumulation  5/404 (1.24%)  7 1/405 (0.25%)  1
Pulmonary edema  5/404 (1.24%)  5 2/405 (0.49%)  3
Cardiac catheterization  5/404 (1.24%)  5 2/405 (0.49%)  2
Cardiovascular medication related  3/404 (0.74%)  3 4/405 (0.99%)  4
Dizziness  4/404 (0.99%)  4 3/405 (0.74%)  3
Pleural effusion  4/404 (0.99%)  4 2/405 (0.49%)  2
Valvular heart disease  4/404 (0.99%)  5 1/405 (0.25%)  1
Abdominal Aortic Aneurysm  3/404 (0.74%)  3 2/405 (0.49%)  2
Edema  1/404 (0.25%)  1 3/405 (0.74%)  3
Increased INR  2/404 (0.50%)  3 1/405 (0.25%)  1
Palpitations  1/404 (0.25%)  1 2/405 (0.49%)  2
Bradycardia  1/404 (0.25%)  1 1/405 (0.25%)  1
Dilated cardiomyopathy  1/404 (0.25%)  1 1/405 (0.25%)  1
Hypertension  1/404 (0.25%)  1 1/405 (0.25%)  1
Ischemic cardiomyopathy  1/404 (0.25%)  1 1/405 (0.25%)  1
Weight gain  2/404 (0.50%)  2 0/405 (0.00%)  0
Fatigue  1/404 (0.25%)  1 0/405 (0.00%)  0
Device related  6/404 (1.49%)  6 9/405 (2.22%)  10
Endocrine disorders     
Endocrine  12/404 (2.97%)  13 4/405 (0.99%)  6
Gastrointestinal disorders     
Gastrointestinal disorder  43/404 (10.64%)  68 28/405 (6.91%)  41
General disorders     
Other noncardiovascular  40/404 (9.90%)  54 36/405 (8.89%)  55
Cancer  5/404 (1.24%)  5 10/405 (2.47%)  13
Traumatic injury  11/404 (2.72%)  12 4/405 (0.99%)  4
Fatigue  3/404 (0.74%)  3 0/405 (0.00%)  0
Hepatobiliary disorders     
Hepatic  1/404 (0.25%)  2 2/405 (0.49%)  2
Infections and infestations     
Infection  58/404 (14.36%)  77 45/405 (11.11%)  54
Musculoskeletal and connective tissue disorders     
Musculoskeletal disorder  25/404 (6.19%)  32 15/405 (3.70%)  18
Nervous system disorders     
Nervous system disorder  13/404 (3.22%)  16 5/405 (1.23%)  5
Headache  0/404 (0.00%)  0 3/405 (0.74%)  4
Renal and urinary disorders     
Renal disorder  28/404 (6.93%)  38 16/405 (3.95%)  19
Respiratory, thoracic and mediastinal disorders     
Respiratory disorder  14/404 (3.47%)  27 22/405 (5.43%)  38
Surgical and medical procedures     
Implantation related  17/404 (4.21%)  19 16/405 (3.95%)  18
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CRT=ON CRT=OFF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   300/404 (74.26%)      274/405 (67.65%)    
Cardiac disorders     
Worsening heart failure  29/404 (7.18%)  32 29/405 (7.16%)  34
Atrial arrhythmia  39/404 (9.65%)  44 35/405 (8.64%)  43
Ventricular arrhythmia  33/404 (8.17%)  39 25/405 (6.17%)  29
Chest pain  20/404 (4.95%)  21 29/405 (7.16%)  32
Dyspnea  20/404 (4.95%)  27 30/405 (7.41%)  32
Hypotension  27/404 (6.68%)  28 27/405 (6.67%)  30
Dizziness  21/404 (5.20%)  25 14/405 (3.46%)  15
Edema  21/404 (5.20%)  23 15/405 (3.70%)  16
ICD lead  28/404 (6.93%)  34 6/405 (1.48%)  6
Lead for left ventricular pacing  49/404 (12.13%)  55 10/405 (2.47%)  11
General disorders     
Non-cardiovascular  203/404 (50.25%)  602 201/405 (49.63%)  548
Surgical and medical procedures     
Implant Procedure  31/404 (7.67%)  33 41/405 (10.12%)  46
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.
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 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