Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1602 participants
OBSERVATIONAL
2023-08-15
2024-10-31
Brief Summary
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This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants phase 1
Phase 1: patients enrolled for a right heart catheterization procedure as part of their standard of care.
Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation.
Participants phase 2
Phase 2: patients enrolled for a right heart catheterization procedure as part of their standard of care.
Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
Interventions
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Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation.
Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization.
No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital.
Eligibility Criteria
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Inclusion Criteria
* Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator.
* Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization.
* Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form.
Exclusion Criteria
* Subjects who are pregnant are excluded in the US
18 Years
ALL
Yes
Sponsors
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Acorai AB
INDUSTRY
Responsible Party
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Locations
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Conway Regional Cardiovascular Clinic
Conway, Arkansas, United States
Baptist Health Medical Centre
Little Rock, Arkansas, United States
Mayo Clinic
Jacksonville, Florida, United States
Cleveland Clinic Martin Health
Stuart, Florida, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
WakeMed
Raleigh, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Austin Heart Central and San Marcos
Austin, Texas, United States
Austin Heart Round Rock
Austin, Texas, United States
Onze-Lieve-Vrouwziekenhuis (OLV) Hospital Aalst
Aalst, , Belgium
University of Ottawa Heart Institute
Ottawa, , Canada
Mount Sinai Hospital Toronto
Toronto, , Canada
Toronto General Hospital
Toronto, , Canada
Rigshospitalet, University Hospital of Copenhagen
Copenhagen, , Denmark
Sahlgrenska university hospital
Gothenburg, , Sweden
Royal Brompton and Harefield Hospitals
London, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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ASDC-1
Identifier Type: -
Identifier Source: org_study_id