A Study to Collect Information Related to the Cordio Medical System

Heart Failure,Congestive Clinical Trial

Official title:

A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720509
• Other study ID #: CA001HY
• Status: Recruiting
• Start date: August 17, 2015
• Est. completion date: November 2022

Study information

• Verified date: April 2020
• Source: Cordio Medical
• Contact: Ronit Haviv, PhD
• Phone: 972-3-5467163
• Email: ronit[@]cordio-med.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center observational non-interventional prospective study. A Single-arm, open, database establishment for R&D purposes when R&D data will be analyzed retrospectively for efficacy at the end of the study.

The study will be conducted in the following settings: Hospital and at home.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic Heart Failure Patient.

• Patient with reduced or preserved EF (ejection fraction) CHF (congestive heart failure).

• The patient is willing to participate as evidenced by signing the written informed consent.

• Male or non-pregnant female patient.

Exclusion Criteria:

• Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).

• Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.

• Subject likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.

• Subject with congenital heart disease or mechanical heart valve(s).

• Subject with known coagulation disorders.

• Subject with evidence of active Infection.

• Patient with severe alcohol or drug use.

• Psychological instability, inappropriate attitude or motivation.

• Patient with life threatening debilitating disease other than cardiac.

• Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Device:
• Cordio Medical
All patients are recorded using the Cordio Medical app, no further intervention

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R&D database for voice signal analysis	Building a sufficient R&D database for device development. Recordings will be analyzed to create the patient voice signal signature (Hz)	throughout study, 1-2 years per patient
Secondary	Usability- SUS (system usability scale)	Cordio Application usability data will be assessed as secondary performance endpoint using SUS scale (0-100 when higher results are better).	throughout study, 1-2 years per patient