Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates

Heart Failure Clinical Trial

— CORELAB-CRT  

Official title:

Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02235766
• Other study ID #: Kell-1
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2014
• Last updated: March 3, 2016
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: Kell s.r.l.
• Contact: Cesare Aragno
• Phone: +39 06 36004916
• Email: caragno[@]kell.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Echocardiographic assessment

Locations

Country	Name	City	State
Italy	S.Camillo de Lellis Hospital	Rieti
Italy	Fatebenefratelli Hospital	Rome
Italy	S.Eugenio Hospital	Rome
Italy	University Hospital Campus Bio-Medico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Kell s.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECM assessment	Agreement in the echocardiographic measurement capability (EMC) between transmitted and echocardiographic device image on the set of high quality images transmitted by STE. Each echo image will be classified as high quality image if the Mean Opinion Score (MOS) will be greater than 3 points. For each high quality echo image (MOS greater or equal 3) the EMC will be assessed to both transmitted and device echocardiographic image.	6 months	No
Secondary	Prognostic efficacy of specific echo parameters	Echocardiographic response defined as LVESV reduction =10% at 6 months after CRT-D implantation.	6 months	No
Secondary	Clinical composite score CCS	CCS describing patients regardless of vital status at 6 months and includes both objective and subjective measures of clinical status.	6 months	No