Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations

Impact of the ProbeFix on the Workflow of Pharmacological Stress Echocardiography Examinations: a Prospective, Randomized Controlled Open Label Study

Pharmacological stress-echocardiography examinations are routinely performed in daily clinical practice. Usually, the echo probe is manually placed on the patient's thorax by the physician. The ProbeFix is a novel device, enabling the fixation of the ultrasound probe on the patient's thorax. Therefore, there is no need to manually hold the probe. This may improve the standardization of the examination and my reduce its duration. The present trial will investigate, whether the utilization of the ProbeFix reduces the duration of stress-echocardiography examinations and improves standardization of image acquisition.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: ProbeFix; Other: Manual hold

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • University Hospital Essen

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients undergoing clinically indicated pharmacological stress-echocardiography
• Willingness to participate

Exclusion Criteria:

• Pharmacological stress echocardiography indication other than evaluation of stress induced ischemia (e.g. Low-Flow-Low-Gradient aortic valve stenoseis)
• poor image quality
• Early termination of the stress-echocardiography examination for clinical reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProbeFix arm; The echocardiography probe is fixated on the patient's thorax using the ProbeFix	Other: ProbeFix; ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
Active Comparator: Controll arm; The sonographer manually holds the probe on the patient's thorax	Other: Manual hold; ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of stress-echocardiography examination	Duration from start of dobutamine infusion to end of stage IV of dobutamine infusion	During the examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography axis deviation in 4 chamber view	In 3-dimensional 4-chamber view, the deviation of the axis as compared to baseline will be assessed	During the examination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness	Assessment of cost-effectiveness, comparing a potential benefit in exam duration with costs of the ProbeFix	During the examination

Collaborators and Investigators

• Sponsor: Amir Abbas Mahabadi

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 19-TEMP815870-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No