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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Heart Failure Ventricular Dyssynchrony | Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1680 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: CRT=ON
Cardiac Resynchronization Therapy activated.
|
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
Other Name: Lumax HF-T CRT-D system |
|
Active Comparator: CRT=OFF
Cardiac Resynchronization Therapy deactivated.
|
Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)
All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF.
Other Name: Lumax HF-T CRT-D system |
- 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 ]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.
- Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free) [ Time Frame: 6 months ]The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population.
- Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year) [ Time Frame: Study duration from randomization to study exit ]Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure (WHF).
- New York Heart Association (NYHA) Classification Change [ Time Frame: 6 months ]
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.
- Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up [ Time Frame: Changes between baseline and 6 months ]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.
- 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) ]
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.
- 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 ]Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women 18 years of age or older.
- Understand the nature of the procedure.
- Give written informed consent.
- Willing and able to complete all testing required by the clinical protocol.
- Indication for an implantable cardioverter defibrillator (ICD).
- NYHA class III-IV within the last three months prior to enrollment and at baseline (at baseline only: also Stage C according to ACC/AHA guidelines).
- Stable optimal pharmacologic therapy for HF.
- An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the baseline echocardiogram.
- Increased left ventricular dimension, defined as LVEDD ≥ 55 mm.
- Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to enrollment and at baseline.
-
Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the echo core lab. One of the two following criteria has to be present to include the subject in the study:
- Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging (TDI) with an opposing wall delay of ≥ 80 ms in the 4-chamber or apical long-axis view.
- Speckle-tracking radial strain septal-posterior wall delay ≥ 130 ms.
Exclusion Criteria:
- Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by device statistics averaged over at least the last three months prior to enrollment.
- Women who are pregnant, lactating, or planning to become pregnant during the course of the trial.
- Bradycardia pacing indication.
- Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn cordae, or flail segment.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 months prior to enrollment.
- Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.
- Angiographic evidence of coronary disease, candidates for coronary revascularization likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the next 3 months.
- Irreversible brain damage from preexisting cerebral disease.
- Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
- Permanent second or third degree heart block.
- Chagas disease.
- Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.
- Expected to receive heart transplantation within six months.
- Current inotropic therapy.
- Acutely decompensated heart failure.
- Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- Life expectancy of less than six months.
- Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer).
- Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221 µmol/L) within the last four weeks prior to enrollment..
- Liver failure, defined as three times the upper limit of normal for aminotransferases.
- Participation in any other clinical trial.
- Unable to return for follow-up visits due to distance from the clinic.
- Do not anticipate being a resident of the area for the scheduled duration of the trial.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683696
Show 122 study locations
| Study Chair: | Frank Ruschitzka, MD | University of Zurich, Switzerland | |
| Study Chair: | Johannes Holzmeister, MD | University of Zurich, Switzerland | |
| Principal Investigator: | William Abraham, MD | Principal Investigator (USA) at The Ohio State University, OH, USA | |
| Principal Investigator: | Jagmeet Singh, MD | Principal Investigator (USA) at Massachusetts General Hospital, MA, USA |
| Responsible Party: | Biotronik, Inc. |
| ClinicalTrials.gov Identifier: | NCT00683696 |
| Other Study ID Numbers: |
EchoCRT |
| First Posted: | May 23, 2008 Key Record Dates |
| Results First Posted: | April 17, 2014 |
| Last Update Posted: | January 17, 2018 |
| Last Verified: | January 2018 |
|
Cardiac Resynchronization Therapy Heart Failure Ventricular Dyssynchrony Mechanical Dyssynchrony Intraventricular Dyssynchrony |
Echocardiography Normal QRS Heart Disease EchoCRT |
|
Heart Failure Heart Diseases Cardiovascular Diseases |