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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT02235766 |
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Date of registration:
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03/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
CORELAB-CRT |
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Scientific title:
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Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02235766 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Cesare Aragno |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kell s.r.l. |
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Name:
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Carlo Peraldo Neja |
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Address:
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Telephone:
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Email:
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Affiliation:
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CORELAB Responsible |
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Name:
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Cesare Aragno |
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Address:
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Telephone:
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+39 06 36004916 |
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Email:
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caragno@kell.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. NYHA class II, III and ambulatory IV with:
- QRS complex duration =120msec;
- Ejection fraction =35%.
2. Optimized medical treatment;
3. Patient in sinus rhythm;
4. Patient is willing and able to sign an informed consent form.
Exclusion Criteria:
1. Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or
percutaneous transluminal coronary angioplasty within the past 3 months;
2. Cerebral vascular attacks or transient ischemic attack within the last month;
3. Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
4. Patients already implanted with an ICD or a CRT device;
5. Pacemaker dependency or ventricular pacing percentage =10%;
6. Valvular disease with an indication for surgical correction =12 months survival
expectancy;
7. Mechanical right ventricular valve;
8. Patient is enrolled in or intends to participate in another clinical trial that may
have an impact on the study endpoints;
9. Pregnancy or breastfeeding;
10. Previous heart transplant;
11. Refusal of study informed consent;
12. Expected lack of compliance during follow-up;
13. Patient is less than 18 years of age;
14. Patient's life expectancy is less than 6 months in the opinion of physician.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Other: Echocardiographic assessment
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Primary Outcome(s)
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ECM assessment
[Time Frame: 6 months]
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Secondary Outcome(s)
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Prognostic efficacy of specific echo parameters
[Time Frame: 6 months]
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Clinical composite score CCS
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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