Corelab Remotely Echocardiographic Imaging Acquisition in Cardiac Resynchronization Therapy Candidates

NCT02235766 | Unknown

• 1 other identifier: Kell-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy; Satellite Tele-Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Prognostic efficacy of specific echo parameters

  6 months

• Clinical composite score CCS

  6 months

Study Arms (1)

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

Interventions

Echocardiographic assessment OTHER

CRT candidates patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kell s.r.l.: lead

Study Sites (4)

S.Camillo de Lellis Hospital

Rieti, 02100, Italy

RECRUITING

S.Eugenio Hospital

Rome, 00144, Italy

RECRUITING

University Hospital Campus Bio-Medico

Rome, 00144, Italy

RECRUITING

Fatebenefratelli Hospital

Rome, 00186, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Carlo Peraldo Neja

  CORELAB Responsible

  PRINCIPAL INVESTIGATOR

• Cesare Aragno

  Kell s.r.l.

  STUDY DIRECTOR

Central Study Contacts

Cesare Aragno

CONTACT

+39 06 36004916; caragno@kell.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 10, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

IT (4)