Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00683696
• Date of registration: 30/08/2007
• Prospective Registration: Yes
• Primary sponsor: Biotronik, Inc.
• Public title: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) EchoCRT
• Scientific title: Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
• Date of first enrolment: August 2008
• Target sample size: 1680
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00683696
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Jagmeet Singh, MD
• Affiliation: Principal Investigator (USA) at Massachusetts General Hospital, MA, USA

• Name: Johannes Holzmeister, MD
• Affiliation: University of Zurich, Switzerland

• Name: William Abraham, MD
• Affiliation: Principal Investigator (USA) at The Ohio State University, OH, USA

• Name: Frank Ruschitzka, MD
• Affiliation: University of Zurich, Switzerland

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Ventricular Dyssynchrony

Intervention(s)

Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

Primary Outcome(s)

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]

Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free) [Time Frame: 6 months]

Secondary Outcome(s)

Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up [Time Frame: Changes between baseline and 6 months]

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)]

New York Heart Association (NYHA) Classification Change [Time Frame: 6 months]

Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year) [Time Frame: Study duration from randomization to study exit]

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]

Secondary ID(s)

EchoCRT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Zurich

Results

• Results available: Yes
• Date Posted: 17/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00683696