Status:
UNKNOWN
Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Lead Sponsor:
Kell s.r.l.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Purpose of the observational study is to assess the capability of a satellite tele-echocardiography (STE) system to acquire and transmit echocardiographic images and clips to an echocardiographic core...
Detailed Description
CORELAB-CRT is a prospective multi center Italian observational study. All echo images and clips will be transmitted by using an integrated satellite transmission system. All echo assessments performe...
Eligibility Criteria
Inclusion
- NYHA class II, III and ambulatory IV with:
- QRS complex duration ≥120msec;
- Ejection fraction ≤35%.
- Optimized medical treatment;
- Patient in sinus rhythm;
- Patient is willing and able to sign an informed consent form.
Exclusion
- Unstable angina, or acute myocardial infarction, coronary-aortic bypass graft or percutaneous transluminal coronary angioplasty within the past 3 months;
- Cerebral vascular attacks or transient ischemic attack within the last month;
- Chronic atrial arrhythmias, paroxysmal atrial fibrillation events;
- Patients already implanted with an ICD or a CRT device;
- Pacemaker dependency or ventricular pacing percentage ≥10%;
- Valvular disease with an indication for surgical correction ≤12 months survival expectancy;
- Mechanical right ventricular valve;
- Patient is enrolled in or intends to participate in another clinical trial that may have an impact on the study endpoints;
- Pregnancy or breastfeeding;
- Previous heart transplant;
- Refusal of study informed consent;
- Expected lack of compliance during follow-up;
- Patient is less than 18 years of age;
- Patient's life expectancy is less than 6 months in the opinion of physician.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02235766
Start Date
March 1 2015
End Date
June 1 2017
Last Update
March 4 2016
Active Locations (4)
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1
S.Camillo de Lellis Hospital
Rieti, Italy, 02100
2
S.Eugenio Hospital
Rome, Italy, 00144
3
University Hospital Campus Bio-Medico
Rome, Italy, 00144
4
Fatebenefratelli Hospital
Rome, Italy, 00186