Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00683696




Registration number
NCT00683696
Ethics application status
Date submitted
30/08/2007
Date registered
23/05/2008
Date last updated
17/01/2018

Titles & IDs
Public title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Scientific title
Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)
Secondary ID [1] 0 0
EchoCRT
Universal Trial Number (UTN)
Trial acronym
EchoCRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Ventricular Dyssynchrony 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)

Experimental: CRT=ON - Cardiac Resynchronization Therapy activated.

Active comparator: CRT=OFF - Cardiac Resynchronization Therapy deactivated.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite Primary Endpoint: Number of Subjects With First Hospitalization for Worsening Heart Failure or Death
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Number of Subjects That Underwent Implant Attempt Without System- or Implant-Related Complications (Complication-Free)
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Rate of Hospitalizations for Worsening Heart Failure (Hospitalizations Per Subject-year)
Timepoint [1] 0 0
Study duration from randomization to study exit
Secondary outcome [2] 0 0
New York Heart Association (NYHA) Classification Change
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Change in Quality of Life (QOL) Scores From Baseline to 6-Month Follow-up
Timepoint [3] 0 0
Changes between baseline and 6 months
Secondary outcome [4] 0 0
Composite Score of Death, Hospitalization for Worsening Heart Failure and Change in Quality of Life (QOL)
Timepoint [4] 0 0
Composite of death, worsening heart failure hospitalization (up to 24 months), and change in QOL (at 6 months)
Secondary outcome [5] 0 0
Number of Subjects With All-cause Mortality
Timepoint [5] 0 0
From date of randomization up to date of study exit, with a mean treatment duration of 1.6 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
1680
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center Adelaide - Adelaide
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedland
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Nedland
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Belgium
State/province [26] 0 0
Aalst
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Edmonton
Country [30] 0 0
Czechia
State/province [30] 0 0
Olomouc
Country [31] 0 0
Czechia
State/province [31] 0 0
Prague
Country [32] 0 0
Denmark
State/province [32] 0 0
Aalborg
Country [33] 0 0
Denmark
State/province [33] 0 0
Aarhus
Country [34] 0 0
Denmark
State/province [34] 0 0
Copenhagen
Country [35] 0 0
Denmark
State/province [35] 0 0
Hellerup
Country [36] 0 0
France
State/province [36] 0 0
Nantes
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
Germany
State/province [39] 0 0
Bad Oeynhausen
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Bernau
Country [42] 0 0
Germany
State/province [42] 0 0
Essen
Country [43] 0 0
Germany
State/province [43] 0 0
Hamburg
Country [44] 0 0
Germany
State/province [44] 0 0
Jena
Country [45] 0 0
Germany
State/province [45] 0 0
Leipzig
Country [46] 0 0
Germany
State/province [46] 0 0
Lunen
Country [47] 0 0
Germany
State/province [47] 0 0
Lüdenscheid
Country [48] 0 0
Germany
State/province [48] 0 0
Magdeburg
Country [49] 0 0
Israel
State/province [49] 0 0
Ashkelon
Country [50] 0 0
Israel
State/province [50] 0 0
Beer Sheva
Country [51] 0 0
Israel
State/province [51] 0 0
Jerusalem
Country [52] 0 0
Israel
State/province [52] 0 0
Tel Aviv
Country [53] 0 0
Israel
State/province [53] 0 0
Tel Hashomer
Country [54] 0 0
Italy
State/province [54] 0 0
Bari
Country [55] 0 0
Italy
State/province [55] 0 0
Brescia
Country [56] 0 0
Italy
State/province [56] 0 0
Naples
Country [57] 0 0
Italy
State/province [57] 0 0
Novara
Country [58] 0 0
Netherlands
State/province [58] 0 0
Amsterdam
Country [59] 0 0
Netherlands
State/province [59] 0 0
Leiden
Country [60] 0 0
Poland
State/province [60] 0 0
Warsaw
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Portugal
State/province [62] 0 0
Lisbon
Country [63] 0 0
Spain
State/province [63] 0 0
Alicante
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Switzerland
State/province [65] 0 0
Geneve
Country [66] 0 0
Switzerland
State/province [66] 0 0
Lausanne
Country [67] 0 0
Switzerland
State/province [67] 0 0
Zurich
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Coventry
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Leicester
Country [70] 0 0
United Kingdom
State/province [70] 0 0
London
Country [71] 0 0
United Kingdom
State/province [71] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Zurich
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frank Ruschitzka, MD
Address 0 0
University of Zurich, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00683696