User Evaluation Study of SyncVision System With Software v4.X

NCT02915991 | Terminated

• 1 other identifier: 2016-CV-001
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

Conditions

Coronary Artery Disease

Keywords

Coronary catheterization; Instantaneous wave free ratio (iFR); Fractional Flow Reserve (FFR); automated co-registration

Outcome Measures

Primary Outcomes (1)

• Professional user feedback regarding clinical utility of the SyncVision 4.X system

  After the procedure the physician will be asked to rate and comment on the clinical utility and features of the SyncVision 4.X system in the post-study user evaluation questionnaire. This will include questions on the potential of the system to facilitate clinical decision-making, utility of co-registration workflow and functionality, quality of the co-registration and user interface functions.

  Day 1 (Post-Procedure)

Secondary Outcomes (3)

• Difference between assessments

  Day 1 (Post-Procedure)

• Distinguish tandem, diffuse and mixed disease

  Day 1 (Post-Procedure)

• Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values

  Day 1 (Post-Procedure)

Study Arms (1)

All patients

This is a single-arm study, so all patients enrolled will be in this arm and will undergo diagnostic catheterization procedure as per standard hospital care.

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

Patiets that undergo a cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice.

You may qualify if:

• Patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice
• Males over the age of 18 years and post-menopausal females
• Patient is able to give written informed consent prior to using his/her study data for evaluation and documentation

You may not qualify if:

• \- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (2)

The medical research and development fund for health services Hillel Yaffe

Hadera, 38100, Israel

Location

Rambam Health Corporation

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Aaron Frimerman, Professor

  The medical research and development fund for health services Hillel Yafe

  PRINCIPAL INVESTIGATOR

• Ariel Roguin, Professor

  Rambam Healthcare Campus

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: September 27, 2016
• Study Start: November 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)