Aortic Valve DiseaseNCT04223713
4D- Flow- MRI After Aortic Valve Surgery
A study testing TriRec and Aortic valve replacement in people with Aortic Valve Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- TriRec and Aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2020to Aug 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
- Aortic annulus > 19 mm
- Written informed consent of the patients.
Who cannot join
- Concomitant intervention of the aortic root, ascending aorta or aortic arch
- Concomitant valve surgery
- Emergency surgery for any reason
- Neurological events (i.e. stroke, TIA) within the previous 6 months
- Coagulation disorders (including thrombocytopenia < 100.000/ml)
- Porcelain aorta/severe calcification of the ascending aorta
Show all 12Show fewer
- Active endocarditis or other active systemic infections
- Participating in another trial that may influence the outcome of this trial
- Pregnancy
- Dual antiplatelet therapy
- Previous cardiac surgery (excluding percutaneous procedures)
- Contraindication for MRI- examinations
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery
Munich, 80636
Anatol Prinzing, MD
About this study
Official title: Changes of Aortic Flow Patterns Detected by 4D- Flow- MRI After Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium Compared to Prosthetic Valve Replacement With Biological Prosthesis
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.
Read the detailed description
Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown.
The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.
The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.
- Conditions
- Aortic Valve Disease
- Being tested
- TriRec, Aortic valve replacement
- Keywords
- aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriRecProcedure or surgery
Trileaflet Reconstruction of the Aortic Valve
Aortic valve replacementProcedure or surgery
Biological Prosthesis, Device: Edwards Perimount
| Study group | Role | What they receive |
|---|---|---|
| TriRec | Experimental | Trileaflet Reconstruction of the Aortic Valve Receives: Procedure: TriRec |
| Aortic valve replacement | Experimental | Biological prosthesis, Device: Edwards Perimount Receives: Procedure: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow velocity in the ascending aorta (m/s)
Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.
Measured: Day 4-7 post surgery
Secondary outcomes (11)
Flow vortices
Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting > 90° from the physiological flow direction.
Measured: Day 4-7 post surgery
Flow helicality
Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
Measured: Day 4-7 post surgery
Systolic eccentricity
Localization of the main blood flow vector (central, little, severe eccentricity).
Measured: Day 4-7 post surgery
Flow patterns in the left ventricular outflow tract.
Flow patterns in the left ventricular outflow tract.
Measured: Day 4-7 post surgery
Effective orifice area (4D-Flow-MRI)
Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)
Measured: Day 4-7 post surgery
Effective orifice area (TTE)
Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)
Measured: Day 4-7 post surgery
Peak- and mean pressure gradients (mmHg, TTE)
Peak- and mean pressure gradients (mmHg, TTE)
Measured: Day 4-7 post surgery
Left- ventricular diameters (mm, TTE)
Left- ventricular diameters (mm, TTE)
Measured: Day 4-7 post surgery
Left- ventricular ejection fraction (%, TTE)
Left- ventricular ejection fraction (%, TTE)
Measured: Day 4-7 post surgery
Quantification of aortic regurgitation (MRI)
Quantification of aortic regurgitation (MRI)
Measured: Day 4-7 post surgery
Quantification of aortic regurgitation (TTE)
Quantification of aortic regurgitation (TTE)
Measured: Day 4-7 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start14 Jan 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223713
- Sponsor's protocol ID
- 77/19-S
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2019
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Aortic Flow Patterns Detected by 4D- Flow- MRI After Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium Compared to Prosthetic Valve Replacement With Biological Prosthesis
- ClinicalTrials.gov ID
- NCT04223713
- Acronym / sponsor ID
- 77/19-S
- Conditions
- Aortic Valve Disease
- Keywords
- aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Jan 2020 (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 randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.
Detailed description
Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown.
The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.
The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TriRec | Experimental | Procedure: TriRecTrileaflet Reconstruction of the Aortic Valve |
| Aortic valve replacement | Experimental | Procedure: Aortic valve replacementBiological prosthesis, Device: Edwards Perimount |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
- Aortic annulus > 19 mm
- Written informed consent of the patients.
Key exclusion criteria (12 listed)
- Concomitant intervention of the aortic root, ascending aorta or aortic arch
- Concomitant valve surgery
- Emergency surgery for any reason
- Neurological events (i.e. stroke, TIA) within the previous 6 months
- Coagulation disorders (including thrombocytopenia < 100.000/ml)
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 |
|---|---|---|
| TriRecTrileaflet Reconstruction of the Aortic Valve | Procedure or surgery | TriRec |
| Aortic valve replacementBiological Prosthesis, Device: Edwards Perimount | Procedure or surgery | Aortic valve replacement |
Primary outcome
Flow velocity in the ascending aorta (m/s)
Time frame: Day 4-7 post surgery
Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.
11 secondary outcomes
Flow vortices
Time frame: Day 4-7 post surgery
Flow helicality
Time frame: Day 4-7 post surgery
Systolic eccentricity
Time frame: Day 4-7 post surgery
Flow patterns in the left ventricular outflow tract.
Time frame: Day 4-7 post surgery
Effective orifice area (4D-Flow-MRI)
Time frame: Day 4-7 post surgery
Effective orifice area (TTE)
Time frame: Day 4-7 post surgery
Peak- and mean pressure gradients (mmHg, TTE)
Time frame: Day 4-7 post surgery
Left- ventricular diameters (mm, TTE)
Time frame: Day 4-7 post surgery
Left- ventricular ejection fraction (%, TTE)
Time frame: Day 4-7 post surgery
Quantification of aortic regurgitation (MRI)
Time frame: Day 4-7 post surgery
Quantification of aortic regurgitation (TTE)
Time frame: Day 4-7 post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
Related trials for Aortic Valve Disease
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriRec and Aortic valve replacement in people with Aortic Valve Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Anatol Prinzing, MD (+49891218 ext. 2777, prinzing@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow velocity in the ascending aorta (m/s) (time frame: Day 4-7 post surgery). 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 2021.