MyoVista wavECG Clinical Evaluation: >=60 y/o Enrichment Population

NCT05364541 | Unknown FDA Device

• 1 other identifier: HS-CLINVAL-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. The study will be conducted at a single investigational site within the United States. Study subjects will predominately be screened from among those who have been enrolled in prior registry studies by the institution.

Conditions

Health Screening

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

  Sensitivity and specificity of the MyoVista for the classification of Low e' where a "positive" includes a MyoVista wavECG result of Positive and Highly Positive. The study result will be considered to have achieved the pre-specified performance criteria for success if the sensitivity is demonstrated to exceed 70% and the specificity is demonstrated to exceed 70%.

  Baseline

Study Arms (1)

MyoVista wavECG

OTHER

Single arm - subjects meeting the inclusion, exclusion and screening criteria will receive a MyoVista wavECG and a trans-thoracic echocardiogram.

Device: MyoVista wavECG

Interventions

MyoVista wavECG DEVICE

A standard 12-Lead, multi-channel resting interpretive trans-thoracic electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information for the detection of Left Ventricular Diastolic Dysfunction.

MyoVista wavECG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is \>=60 years of age
• Subjects will predominately be recruited among those who are already enrolled in existing registry studies within the institution.
• The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).

You may not qualify if:

• The subject has current acute coronary syndrome, decompensated heart failure or stroke
• The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
• Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
• The subject is pregnant at the time of the study testing
• The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
• Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
• The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences.

Sponsors & Collaborators

• Heart Test Laboratories, Inc.: lead

Study Sites (1)

University of Texas Medical Center

Dallas, Texas, 75390, United States

Location

Study Officials

• Partho Sengupta, MD

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 6, 2022
• Study Start: June 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: November 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)