Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates (CORELAB-CRT)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Other: Echocardiographic assessment

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Italy
  • Rieti, Italy, 02100
    • Recruiting
    • S.Camillo de Lellis Hospital
    • Contact: Serafino Orazi, MD
    • Principal Investigator: Serafino Orazi, MD
    • Sub-Investigator: Giuseppe Stifano, MD
  • Rome, Italy, 00144
    • Recruiting
    • S.Eugenio Hospital
    • Contact: Filippo Lamberti, MD
    • Principal Investigator: Filippo Lamberti, MD
    • Sub-Investigator: Francesca Di Clemente, MD
  • Rome, Italy, 00144
    • Recruiting
    • University Hospital Campus Bio-Medico
    • Contact: Simona Mega, MD
    • Principal Investigator: Simona Mega, MD
    • Sub-Investigator: Danilo Ricciardi, MD
  • Rome, Italy, 00186
    • Recruiting
    • Fatebenefratelli Hospital
    • Contact: Gaetano Luca Panetta, MD
    • Principal Investigator: Gaetano Luca Panetta, MD
    • Sub-Investigator: Francesca Toscano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CRT candidates patients; 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.	Other: Echocardiographic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic efficacy of specific echo parameters	Echocardiographic response defined as LVESV reduction ≥10% at 6 months after CRT-D implantation.	6 months
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

Collaborators and Investigators

• Sponsor: Kell s.r.l.
• Investigators: Principal Investigator: Carlo Peraldo Neja, CORELAB Responsible; Study Director: Cesare Aragno, Kell s.r.l.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization Therapy; Satellite Tele-Echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Kell-1