Heart FailureNCT03430102
Indicor Validation
An observational study of Heart Failure, run by Vixiar Medical, Inc. at 4 sites in United States.
Trial summary
The study is designed to repeat an initial training set study conducted at Johns Hopkins Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively measured LVEDP via direct measurement via left… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Indicor
- How many people
- 289 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Feb 2018to 12 Mar 2020
- Phase
- Observational
- 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
Study population: Patients scheduled to undergo cardiac catheterization as part of their routine care and clinically indicated
Who may be able to join
- -Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)
Who cannot join
- Weight <88 pounds (40 kilograms)
- Atrial flutter or atrial fibrillation with an irregular ventricular response
- Significant atrial or ventricular ectopy
- History of paradoxical emboli
- Hypertrophic obstructive cardiomyopathy
- History of paradoxical emboli
Show all 15Show fewer
- Known intracardiac shunt
- Known severe aortic valve stenosis or known severe mitral valve stenosis
- History of embolic cerebrovascular accident
- Clinically unstable
- Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP> 100 mmHg)
- Hypotension (systolic BP <90 mmHg)
- Symptomatic bradycardia
- Known cholesterol emboli
- Poor LV function with known LV thrombus
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Lancaster General Health
Lancaster, Pennsylvania, 17603
Christiana Care
Newark, Delaware, 19713
Stony Brook Medicine
Stony Brook, New York, 11794
About this study
Official title: Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP
The study is designed to repeat an initial training set study conducted at Johns Hopkins Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively measured LVEDP via direct measurement via left heart catheterization. The study is divided into an initial training set, followed by the validation set which is designed to support an FDA 510(k) submission and validate the final algorithm. Patients will be enrolled who are scheduled to undergo a cardiac catheterization and will be asked to perform three tests with the Indicor.
Read the detailed description
Patients who are scheduled to undergo a left heart cardiac catheterization for direct measure of left ventricular end diastolic pressure (LVEDP) as part of routine care will be asked to participate. Investigators will take non-invasive measures of LVEDP using the Indicor device, repeated at three time points before and after the catheterization procedure. The Indicor indirectly measures LVEDP by calculating a value from finger photoplethysmography (PPG) waveforms that will be recorded while the patient performs a Valsalva maneuver.
Participants baseline characteristics will be gathered from the electronic medical record, including history of coronary artery disease, heart failure, hypertension, diabetes, or lung disease; list of blood pressure medications; serum markers of kidney function; and echocardiogram measurements including ejection fraction. These parameters will be used to assess relevance to the calculation of LVEDP by Indicor.
The first Indicor measure will be conducted before the catheterization procedure. PPG probes will be attached to participants' first or second finger. Participants will be asked to strain as if having a bowel movement (Valsalva maneuver) for 10 seconds. Participants will blow into a pressure transducer that measures and displays the pressure of their effort. The Indicor device will acquire 3 successful efforts.
During the cardiac catheterization, while the pressure transducer used by the clinical team to measure LVEDP is in the aorta, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts. This will allow investigators to determine how well the amplitude changes of the PPG signal during Valsalva maneuver reflect the amplitude changes of central arterial pressure during the Valsalva maneuver. According to experienced catheterization cardiologists, this set of tests will not add significant risk to the procedure. This second set of tests may not be performed in all participants.
Immediately after the cardiac catheterization, while the patient is still on the catheterization table, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts.
- Conditions
- Heart Failure
- Being tested
- Indicor
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndicorDiagnostic test
Calculation of LVEDP via analysis of PPG waveform with Valsalva
| Study group | Role | What they receive |
|---|---|---|
| LeftHeartCath | Patients scheduled for LV catheterization for direct measurement of LVEDP Receives: Diagnostic Test: Indicor |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-LVEDP
Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) > 20 mmHg
Measured: During patients scheduled left heart cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start14 Feb 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vixiar Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harry Silber, MD, PhD, Principal investigator, Johns Hopkins Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430102
- Sponsor's protocol ID
- Pro00022390
- Status last verified
- Jun 2020
- First submitted
- 29 Jan 2018
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gilotra NA, Tedford RJ, Wittstein IS, Yenokyan G, Sharma K, Russell SD, Silber HA. Usefulness of Pulse Amplitude Changes During the Valsalva Maneuver Measured Using Finger Photoplethysmography to Identify Elevated Pulmonary Capillary Wedge Pressure in Patients With Heart Failure. Am J Cardiol. 2017 Sep 15;120(6):966-972. doi: 10.1016/j.amjcard.2017.06.029. Epub 2017 Jun 28.
PubMed 28754567Galiatsatos P, Win TT, Monti J, Johnston PV, Herzog W, Trost JC, Hwang CW, Fridman GY, Wang NY, Silber HA. Usefulness of a Noninvasive Device to Identify Elevated Left Ventricular Filling Pressure Using Finger Photoplethysmography During a Valsalva Maneuver. Am J Cardiol. 2017 Apr 1;119(7):1053-1060. doi: 10.1016/j.amjcard.2016.11.063. Epub 2017 Jan 5.
PubMed 28185634Silber HA, Trost JC, Johnston PV, Maughan WL, Wang NY, Kasper EK, Aversano TR, Bush DE. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol. 2012 May 15;302(10):H2043-7. doi: 10.1152/ajpheart.00609.2011. Epub 2012 Mar 2.
PubMed 22389389Sharma GV, Woods PA, Lambrew CT, Berg CM, Pietro DA, Rocco TP, Welt FW, Sacchetti P, McIntyre KM. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch Intern Med. 2002 Oct 14;162(18):2084-8. doi: 10.1001/archinte.162.18.2084.
PubMed 12374516Gillard C, Henuzet C, Lallemand J, Moscariello A, Guillaume M, Van Meerhaeghe A. Operating characteristics of the Finapress system to predict elevated left ventricular filling pressure. Clin Cardiol. 2006 Mar;29(3):107-11. doi: 10.1002/clc.4960290305.
PubMed 16596832Zema MJ. Bedside assessment of cardiac hemodynamics: role of the simple Valsalva maneuver. Am J Med. 2012 Aug;125(8):e13; author reply e15-6. doi: 10.1016/j.amjmed.2011.12.020. No abstract available.
PubMed 22840672Felker GM, Cuculich PS, Gheorghiade M. The Valsalva maneuver: a bedside "biomarker" for heart failure. Am J Med. 2006 Feb;119(2):117-22. doi: 10.1016/j.amjmed.2005.06.059.
PubMed 16443410Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
PubMed 2913385
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP
- ClinicalTrials.gov ID
- NCT03430102
- Acronym / sponsor ID
- Pro00022390
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Vixiar Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 12 Feb 2018 (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.
The study is designed to repeat an initial training set study conducted at Johns Hopkins Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively measured LVEDP via direct measurement via left heart catheterization. The study is divided into an initial training set, followed by the validation set which is designed to support an FDA 510(k) submission and validate the final algorithm. Patients will be enrolled who are scheduled to undergo a cardiac catheterization and will be asked to perform three tests with the Indicor.
Detailed description
Patients who are scheduled to undergo a left heart cardiac catheterization for direct measure of left ventricular end diastolic pressure (LVEDP) as part of routine care will be asked to participate. Investigators will take non-invasive measures of LVEDP using the Indicor device, repeated at three time points before and after the catheterization procedure. The Indicor indirectly measures LVEDP by calculating a value from finger photoplethysmography (PPG) waveforms that will be recorded while the patient performs a Valsalva maneuver.
Participants baseline characteristics will be gathered from the electronic medical record, including history of coronary artery disease, heart failure, hypertension, diabetes, or lung disease; list of blood pressure medications; serum markers of kidney function; and echocardiogram measurements including ejection fraction. These parameters will be used to assess relevance to the calculation of LVEDP by Indicor.
The first Indicor measure will be conducted before the catheterization procedure. PPG probes will be attached to participants' first or second finger. Participants will be asked to strain as if having a bowel movement (Valsalva maneuver) for 10 seconds. Participants will blow into a pressure transducer that measures and displays the pressure of their effort. The Indicor device will acquire 3 successful efforts.
During the cardiac catheterization, while the pressure transducer used by the clinical team to measure LVEDP is in the aorta, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts. This will allow investigators to determine how well the amplitude changes of the PPG signal during Valsalva maneuver reflect the amplitude changes of central arterial pressure during the Valsalva maneuver. According to experienced catheterization cardiologists, this set of tests will not add significant risk to the procedure. This second set of tests may not be performed in all participants.
Immediately after the cardiac catheterization, while the patient is still on the catheterization table, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LeftHeartCath | – | Diagnostic Test: IndicorPatients scheduled for LV catheterization for direct measurement of LVEDP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo cardiac catheterization as part of their routine care and clinically indicated
Key inclusion criteria (1 listed)
- -Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)
Key exclusion criteria (15 listed)
- Weight <88 pounds (40 kilograms)
- Atrial flutter or atrial fibrillation with an irregular ventricular response
- Significant atrial or ventricular ectopy
- History of paradoxical emboli
- Hypertrophic obstructive cardiomyopathy
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 |
|---|---|---|
| IndicorCalculation of LVEDP via analysis of PPG waveform with Valsalva | Diagnostic test | LeftHeartCath |
Primary outcome
C-LVEDP
Time frame: During patients scheduled left heart cardiac catheterization
Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) > 20 mmHg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 28754567Gilotra NA, Tedford RJ, Wittstein IS, Yenokyan G, Sharma K, Russell SD, Silber HA. Usefulness of Pulse Amplitude Changes During the Valsalva Maneuver Measured Using Finger Photoplethysmography to Identify Elevated Pulmonary Capillary Wedge Pressure in Patients With Heart Failure. Am J Cardiol. 2017 Sep 15;120(6):966-972. doi: 10.1016/j.amjcard.2017.06.029. Epub 2017 Jun 28.
- Background: PubMed 28185634Galiatsatos P, Win TT, Monti J, Johnston PV, Herzog W, Trost JC, Hwang CW, Fridman GY, Wang NY, Silber HA. Usefulness of a Noninvasive Device to Identify Elevated Left Ventricular Filling Pressure Using Finger Photoplethysmography During a Valsalva Maneuver. Am J Cardiol. 2017 Apr 1;119(7):1053-1060. doi: 10.1016/j.amjcard.2016.11.063. Epub 2017 Jan 5.
- Background: PubMed 22389389Silber HA, Trost JC, Johnston PV, Maughan WL, Wang NY, Kasper EK, Aversano TR, Bush DE. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol. 2012 May 15;302(10):H2043-7. doi: 10.1152/ajpheart.00609.2011. Epub 2012 Mar 2.
- Background: PubMed 12374516Sharma GV, Woods PA, Lambrew CT, Berg CM, Pietro DA, Rocco TP, Welt FW, Sacchetti P, McIntyre KM. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch Intern Med. 2002 Oct 14;162(18):2084-8. doi: 10.1001/archinte.162.18.2084.
- Background: PubMed 16596832Gillard C, Henuzet C, Lallemand J, Moscariello A, Guillaume M, Van Meerhaeghe A. Operating characteristics of the Finapress system to predict elevated left ventricular filling pressure. Clin Cardiol. 2006 Mar;29(3):107-11. doi: 10.1002/clc.4960290305.
- Background: PubMed 22840672Zema MJ. Bedside assessment of cardiac hemodynamics: role of the simple Valsalva maneuver. Am J Med. 2012 Aug;125(8):e13; author reply e15-6. doi: 10.1016/j.amjmed.2011.12.020. No abstract available.
- Background: PubMed 16443410Felker GM, Cuculich PS, Gheorghiade M. The Valsalva maneuver: a bedside "biomarker" for heart failure. Am J Med. 2006 Feb;119(2):117-22. doi: 10.1016/j.amjmed.2005.06.059.
- Background: PubMed 2913385Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
- 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.
Harry Silber, MD, PhD principal investigator
Johns Hopkins Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Vixiar Medical, Inc. at 4 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 1 inclusion and 15 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: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C-LVEDP (time frame: During patients scheduled left heart cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430102, which also lists 8 linked publications.
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 17 Jun 2020.