Cardiovascular DiseasesIDENTIFY - PHNCT04031989
Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
A study testing CorVista Capture in people with Cardiovascular Diseases and Right Heart Failure, run by Analytics For Life at 17 sites in United States.
Trial summary
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Right Heart Failure, Cardiac Disease
- What is being tested?
- CorVista Capture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 17 sitesUnited States
- Study dates
- 15 Apr 2019to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old;
- Scheduled to undergo right heart catheterization;
- Ability to understand the requirements of the study and to provide written informed consent.
- Normal Sinus Rhythm (SSR) at time of phase signal collection.
Who cannot join
- Prior heart valve replacement
- Prior lung or heart transplant
- Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
- Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors;
- Implantable Neuro-stimulators;
- Congenital Heart Disease;
Show all 12Show fewer
- Pregnant or breast feeding;
- Currently taking any Type IA, IC or III antiarrhythmics;
- Any history of amiodarone use;
- Clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum);
- Breast implants;
- Neuromuscular Disease if the condition results in tremor or muscle fasciculations.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
AnMed Health
Anderson, South Carolina, 29621
Austin Heart
Austin, Texas, 78756
Medical University of South Carolina
Charleston, South Carolina, 29425
UC-MHS (UCHealth Memorial)
Colorado Springs, Colorado, 80909
University of Colorado-MHS (UCHealth Memorial)
Colorado Springs, Colorado, 80920
Duke University
Durham, North Carolina, 27710
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Lexington Cardiology / Lexington Medical Heart and Vascular Center
Lexington, South Carolina, 29169
Bryan Heart
Lincoln, Nebraska, 68506
WellStar Research Institute
Marietta, Georgia, 30060
Loyola University Chicago
Maywood, Illinois, 60153
Allegheny Health Network Research Institute
Natrona Heights, Pennsylvania, 15065
Sentara Hospitals and Sentara Medical Group
Norfolk, Virginia, 23507
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
The Rochester General Hospital
Rochester, New York, 14621
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
Official title: Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).
Read the detailed description
Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.
- Being tested
- CorVista Capture
- Keywords
- Pulmonary Hypertension, Right Heart Cath
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Heart Diseases, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorVista CaptureDevice
The CorVista System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms developed by CorVista Health. Data collected with the CorVista System during this study will not be used to guide treatment.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects (PSR) | Other | Patients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure. Receives: Device: CorVista Capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Signal Recorder Procedure
Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start15 Apr 2019
- Primary completion15 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repository study designed to collect signals using the CorVista Capture in subjects scheduled for Right Heart Catheterization
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Analytics For Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Horace R Gillins, BS CCRP, Study director, CorVista HealthWilliam E Sanders, Jr, MD JD LLM MBA FHRS, Study director, CorVista Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031989
- Sponsor's protocol ID
- PHDEV-CIP-001
- Acronym
- IDENTIFY - PH
- Status last verified
- Mar 2024
- First submitted
- 23 Jul 2019
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Signal Acquisition System (PSAQ): Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
- ClinicalTrials.gov ID
- NCT04031989
- Acronym / sponsor ID
- IDENTIFY - PH / PHDEV-CIP-001
- Keywords
- Pulmonary Hypertension, Right Heart Cath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Analytics For LifeIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to Right Heart Cath (RHC). The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by CorVista Health (formerly Analytics 4 Life).
Detailed description
Male and Female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. Resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. This study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. In this study, resting phase signals will be acquired in subjects prior to Right Heart Catheterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repository study designed to collect signals using the CorVista Capture in subjects scheduled for Right Heart Catheterization
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects (PSR) | Other | Device: CorVista CapturePatients who meet the study's entrance criteria and provide written informed consent, will undergo signal acquisition prior to their scheduled right heart catheterization (RHC) on the day of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥ 18 years old;
- Scheduled to undergo right heart catheterization;
- Ability to understand the requirements of the study and to provide written informed consent.
- Normal Sinus Rhythm (SSR) at time of phase signal collection.
Key exclusion criteria (12 listed)
- Prior heart valve replacement
- Prior lung or heart transplant
- Infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia);
- Presence of cardiac implantable electronic device (CIED), including implantable cardioverter defibrillator (ICD), pacemaker (PM), implantable loop recorders and other monitors;
- Implantable Neuro-stimulators;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorVista CaptureThe CorVista System is a medical device system that is being developed to collect phase signals from patients to support the development and testing of machine learned algorithms developed by CorVista Health. Data collected with the CorVista System during this study will not be used to guide treatment. | Device | Enrolled Subjects (PSR) |
Primary outcome
Phase Signal Recorder Procedure
Time frame: 7 day
Resting phase signals will be collected from eligible subjects prior to Right Heart Catheterization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horace R Gillins, BS CCRP study director
CorVista Health
William E Sanders, Jr, MD JD LLM MBA FHRS study director
CorVista Health
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorVista Capture in people with Cardiovascular Diseases and Right Heart Failure, run by Analytics For Life at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Signal Recorder Procedure (time frame: 7 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.