An observational study in Valve Heart Disease, sponsored by CryoLife, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-04.
Sponsored by CryoLife, Inc. · Observational
Among 110 studies in Heart Valve Diseases with a site in United States — 38 open to participants now, 49 under way, none of them phase 3. Heart Valve Diseases · United States.
Among the 110 studies in Heart Valve Diseases with a site in United States, this one is the 41st largest by enrollment of the 45 observational ones that give a count, is one of 6 that started in 2017, is one of 45 observational ones, and was the 40th registered.
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
Browse Heart Valve Diseases studies →38 of the 110 studies in Heart Valve Diseases with a site in United States are open now. Recruiting first, the newest first:
Edwards Lifesciences · Sites in United States
Medtronic Cardiovascular · Sites in United States
Laplace Interventional, Inc · Sites in United States
VDyne, Inc. · Sites in United States
The Cleveland Clinic · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 118 Heart Valve Diseases studies recruiting now, 93 (79%) set no upper age limit and 10 (8%) stop at 75 or younger; 16 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
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110 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 6 started in 2017.
This study's enrollment of 20 is below the median of 300 across 226 observational studies indexed under Heart Valve Diseases.
Median enrollment 186 across the 65 interventional studies, 353 across the 45 observational. Of the 54 that completed or were terminated, 30 (56%) have results posted.
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58 of 110 have an industry lead sponsor. The 10 most frequent:
CryoLife, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
CryoLife, Inc. has 1 study filed under Heart Valve Diseases — fewer than ten, so there is no comparison to draw.
13 of the studies in Heart Valve Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06965725Endeavor HealthPaired-Ring Mitral Annuloplasty Ring Sizing Device | 2026-11 |
| NCT04843371Tulane UniversityPPG to Predict Ejection Fraction and Other Echographic Data in the General Population | 2026-12 |
| NCT03142152Cardiac Dimensions, Inc.The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR | 2026-12-31 |
| NCT07224906HemoCept Inc.Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization | 2027-01 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
Among the 110 studies in Heart Valve Diseases with a site in United States, from their registry updates:
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The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.
Prospective, concurrent 4D flow Magnetic Resonance Imaging (MRI) and echocardiography of On-X and St Jude Medical (SJM) Masters HP or Carbomedics Carbo-seal or Carbo-seal Valsalva aortic valve replacement (AVR) patients will be performed. Echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. MRI analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.
Patients with aortic valve disease who within the last five years underwent AVR using the On-X aortic valve, SJM Masters HP, or Carbomedics aortic valves.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with prior AVR surgery with the CryoLife On-X Ascending Aortic Prosthesis (AAP).
Other: MRI · Other: Transthoracic echocardiography exam
Patients with St. Jude Medical Masters HP Valved Graft with Gelweave Valsalva™ Technology or Carbomedics Carbo-seal (including Carbo-seal Valsalva) mechanical aortic valve prostheses patients
Other: MRI · Other: Transthoracic echocardiography exam
Enrolled patients will complete a non-contrast cardiac MRI
Enrolled patients will complete a transthoracic echocardiography exam.
Downstream flow patterns (helicity and vorticity)
MRI data analysis; Helicity and vorticity graded (1-3) by blinded reviewers.
Time frame: 3 months
Hinge washout
MRI data analysis; Yes/No
Time frame: 3 months
Energy loss
MRI data analysis; Irreversible energy loss quantified.Efforts will include the quantification of turbulent kinetic energy. This is representative of permanent pressure loss.
Time frame: 3 months
Wall shear stress (WSS)
MRI data analysis; WSS, the tangential force exerted by blood flow on the vessel wall, measured in the anastomosis regions
Time frame: 3 months
Ejection Fraction (%)
Time frame: 3 months
Primary EDV (ml)
End Diastolic Volume
Time frame: 3 months
Normalized EDV (ml/m^2)
End Diastolic Volume
Time frame: 3 months
Primary ESV (mL)
End Systolic Volume
Time frame: 3 months
Normalized ESV (mL/m^2)
End Systolic Volume
Time frame: 3 months
Peak Velocity (m/s)
Time frame: 3 months
Mean velocity (m/s)
Time frame: 3 months
Peak transvalvular pressure gradient (mmHg)
Time frame: 3 months
Mean transvalvular pressure gradient (mmHg)
Time frame: 3 months
Effective Orifice Area (EOA)
Time frame: 3 months
Effective Orifice Area index (EOAi)
Time frame: 3 months
Ran from Oct 2017 to primary completion in Jun 2020, 31 months.
Of 115 observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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CryoLife, Inc.