Clinical trial NCT02235766: Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Official title: Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy
Satellite Tele-Echocardiography
Lead sponsor: Kell s.r.l.
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In accordance with the current ESC/ACCF/AHA indications for CRT in sinus rhythm, all patients in NYHA class II, III and IV with QRS complex greater than 120 msec and ejection fraction equal or less than 35% will be considered eligible to participate in this observational study.

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 laboratory (ECL) in a real time mode without loss of quality. Additionally the prognostic efficacy of specific echo parameters in the cardiac resynchronization therapy response will be evaluated.

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 performed in accordance to the centers clinical practice will be also used to investigate the prognostic efficacy of echo parameters in term of response to the cardiac resynchronization therapy (CRT). All commercially available multi-chamber CRT-D devices from any manufacturers are allowed in this observational study.

Any compatible market released right atrial, right ventricular and left ventricular lead from any manufacturer is allowed.

The echocardiography device models used to perform echo imaging for all patients participating in this analysis are GE Vivid 7, GE Vivid 9 and GE Vivid I, according to the model used in the clinical practice of the hospital.

Eligibility criteria: 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.

Primary outcomes:
measure: ECM assessment
timeFrame: 6 months
Secondary outcomes:
measure: Prognostic efficacy of specific echo parameters
timeFrame: 6 months
measure: Clinical composite score CCS
timeFrame: 6 months
Other outcomes:
Locations:
city: Rieti
country: Italy
facility: S.Camillo de Lellis Hospital
city: Rome
country: Italy
facility: S.Eugenio Hospital
city: Rome
country: Italy
facility: University Hospital Campus Bio-Medico
city: Rome
country: Italy
facility: Fatebenefratelli Hospital
Study officials:
affiliation: CORELAB Responsible
name: Carlo Peraldo Neja
role: PRINCIPAL_INVESTIGATOR
affiliation: Kell s.r.l.
name: Cesare Aragno
role: STUDY_DIRECTOR
References: