Aortic Valve Disease MixedValve in RootNCT06697249
Feasibility of Valve-in-Root Transcatheter Aortic Valve Implantation in 363 Patients After Aortic Root Replacement and Repair
An observational study of Aortic Valve Disease Mixed and Transcatheter Aortic Valve Replacement, run by Alicja Zientara at 1 site in Germany.
Trial summary
Biological replacement of the aortic valve in the sense of a complete root replacement is the therapy for a dilatation or aneurysm of the ascending aorta, which also involves the aortic valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease Mixed, Transcatheter Aortic Valve Replacement
- What is being tested?
- Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantation
- How many people
- 760 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2024to 20 Jun 2024
- 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: From January 2012 till December 2022, 760 patients underwent either an aortic root replacement or valve-sparing root replacement using the David technique. All patients over the age of 18 were included. The exclusion criteria were mechanical aortic root replacements and a missing postoperative ECG-gated CT-angiography scan of the thoracic aorta resulting in cumulatively 363 patients after either biological root replacement or root repair. The CT scans were obtained before discharge or during the first two years after the operation in the context of the routine postoperative follow-up.
Who may be able to join
- all patients over 18 years after biological aortic root replacement or repair
- postoperative ECG-gated CT-angiography scan
Who cannot join
- mechanical aortic root replacements (not suitable for Valve-in-Root treatment)
- missing postoperative ECG-gated CT-angiography scan
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital Freiburg, Department of Cardiovascular Surgery
Freiburg im Breisgau, 79106
About this study
Official title: Feasibility of Valve-in-Root Transcatheter Aortic Valve Implantation in 363 Patients After Aortic Root Replacement and Repair: a Retrospective Computed-tomography Analysis
Biological replacement of the aortic valve in the sense of a complete root replacement is the therapy for a dilatation or aneurysm of the ascending aorta, which also involves the aortic valve. In some patients, the aortic valve can be preserved, which means that only reconstruction is necessary instead of a complete replacement of the root. For a root replacement or root reconstruction, both coronary arteries must be prepared at their origin from the aorta and reimplanted into a tubular prosthesis. It is known that biological aortic valve prostheses have a lifespan of between 10-20 years depending on the type and design of the valve and that the first degenerative symptoms become visible after 10-12 years. This is particularly relevant for patients who have their initial operation at a younger age and require a follow-up procedure if the valve degenerates at an older age.
The minimally invasive implantation of transcatheter valves has proven to be a successful method, avoiding a second operation with an increased risk of mortality. The so-called valve-in-valve procedures are carried out particularly in older patients and are now standard in modern valve treatment. The feasibility of a valve-in-valve in the aortic position requires certain anatomical conditions, which can be influenced by the surgeon's implantation technique in the case of additional root replacement. In particular, there is a risk of coronary artery occlusion when implanting the transcatheter valve, which is increased if the coronary artery branches are located below the valve level. In addition, the selection of the prosthesis size is an important parameter for subsequently implanting a suitably large transcatheter valve.
Read more
The aim of this study is to use postoperative computer tomography of patients after root replacement/reconstruction to measure the anatomical parameters that describe a possible implantation of a transcatheter valve in the event of degeneration of the initial valve. This simultaneously shows the quality of the root replacement/reconstruction with regard to a plannable follow-up procedure and can also show for the future how the surgical technique could be modified to make a minimally invasive follow-up intervention available to more patients.
This study aims to answer the question of whether the patients who were treated with biological root replacement or reconstruction in the years 2012-2022 for aortic valve failure are anatomically suitable for valve-in-valve therapy based on the postoperative computed tomography measurements of the aortic root. In addition, the measurements provide a surgical answer to the question of whether relevant parameters such as the distance between the coronary arteries were sufficiently taken into account during the initial operation or whether an improvement should be made in the future while adhering to the anatomically important parameters during the initial procedure.
- Being tested
- Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantation
- Keywords
- Valve-in-root aortic valve replacement, transcatheter aortic valve replacement, root replacement, valve-sparing aortic root replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantationOther
CT scans of patients after biological root replacement and root repair were assessed with the 3mensio Software (Aortic valve package, 3mensio 10.1, Pie Medical Imaging. Before carrying out the measurements, markers for alignment of the aortic root and ascending aorta were placed manually. The annular area was measured for both groups. In patients after biological root replacement the area of the annulus was defined as the ring of the initial aortic valve prosthesis. Coronary buttons were measured at their lowest and highest point to define partial or full position below the valve level and the general button size. For assessment of the annular-to-coronary distance, the lower edge of the coronary button was chosen. VTC was assessed after root replacement in patients who had at least one coronary partially under the level of the valve. For this measurement a virtually inserted valve was placed in the bioprosthetic frame.
| Study group | Role | What they receive |
|---|---|---|
| RR patients | Patients after biological aortic root replacement Receives: Other: Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantation | |
| VSRR patients | Patients after valve-sparing aortic root replacement Receives: Other: Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT-measurement: Aortic annulus area
Measured: January 2024-June 2024
CT-measurement: Valve-to-coronary distance
Measured: January 2024-June 2024
CT measurement: Annulus-to-coronary distance
Measured: January 2024-June 2024
CT-measurement: Size of coronary buttons
Measured: January 2024-June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start10 Jan 2024
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve Disease MixedStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alicja Zientara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alicja Zientara, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697249
- Sponsor's protocol ID
- ViR 2024
- Acronym
- Valve in Root
- Status last verified
- Nov 2024
- First submitted
- 2 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Valve-in-Root Transcatheter Aortic Valve Implantation in 363 Patients After Aortic Root Replacement and Repair: a Retrospective Computed-tomography Analysis
- ClinicalTrials.gov ID
- NCT06697249
- Acronym / sponsor ID
- Valve in Root / ViR 2024
- Keywords
- Valve-in-root aortic valve replacement, transcatheter aortic valve replacement, root replacement, valve-sparing aortic root replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Alicja ZientaraUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 20 Nov 2024 (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.
Biological replacement of the aortic valve in the sense of a complete root replacement is the therapy for a dilatation or aneurysm of the ascending aorta, which also involves the aortic valve. In some patients, the aortic valve can be preserved, which means that only reconstruction is necessary instead of a complete replacement of the root. For a root replacement or root reconstruction, both coronary arteries must be prepared at their origin from the aorta and reimplanted into a tubular prosthesis. It is known that biological aortic valve prostheses have a lifespan of between 10-20 years depending on the type and design of the valve and that the first degenerative symptoms become visible after 10-12 years. This is particularly relevant for patients who have their initial operation at a younger age and require a follow-up procedure if the valve degenerates at an older age.
The minimally invasive implantation of transcatheter valves has proven to be a successful method, avoiding a second operation with an increased risk of mortality. The so-called valve-in-valve procedures are carried out particularly in older patients and are now standard in modern valve treatment. The feasibility of a valve-in-valve in the aortic position requires certain anatomical conditions, which can be influenced by the surgeon's implantation technique in the case of additional root replacement. In particular, there is a risk of coronary artery occlusion when implanting the transcatheter valve, which is increased if the coronary artery branches are located below the valve level. In addition, the selection of the prosthesis size is an important parameter for subsequently implanting a suitably large transcatheter valve.
The aim of this study is to use postoperative computer tomography of patients after root replacement/reconstruction to measure the anatomical parameters that describe a possible implantation of a transcatheter valve in the event of degeneration of the initial valve. This simultaneously shows the quality of the root replacement/reconstruction with regard to a plannable follow-up procedure and can also show for the future how the surgical technique could be modified to make a minimally invasive follow-up intervention available to more patients.
This study aims to answer the question of whether the patients who were treated with biological root replacement or reconstruction in the years 2012-2022 for aortic valve failure are anatomically suitable for valve-in-valve therapy based on the postoperative computed tomography measurements of the aortic root. In addition, the measurements provide a surgical answer to the question of whether relevant parameters such as the distance between the coronary arteries were sufficiently taken into account during the initial operation or whether an improvement should be made in the future while adhering to the anatomically important parameters during the initial procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RR patients | – | Other: Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantationPatients after biological aortic root replacement |
| VSRR patients | – | Other: Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantationPatients after valve-sparing aortic root replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2012 till December 2022, 760 patients underwent either an aortic root replacement or valve-sparing root replacement using the David technique. All patients over the age of 18 were included. The exclusion criteria were mechanical aortic root replacements and a missing postoperative ECG-gated CT-angiography scan of the thoracic aorta resulting in cumulatively 363 patients after either biological root replacement or root repair. The CT scans were obtained before discharge or during the first two years after the operation in the context of the routine postoperative follow-up.
Key inclusion criteria (2 listed)
- all patients over 18 years after biological aortic root replacement or repair
- postoperative ECG-gated CT-angiography scan
Key exclusion criteria (2 listed)
- mechanical aortic root replacements (not suitable for Valve-in-Root treatment)
- missing postoperative ECG-gated CT-angiography scan
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 |
|---|---|---|
| Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantationCT scans of patients after biological root replacement and root repair were assessed with the 3mensio Software (Aortic valve package, 3mensio 10.1, Pie Medical Imaging. Before carrying out the measurements, markers for alignment of the aortic root and ascending aorta were placed manually. The annular area was measured for both groups. In patients after biological root replacement the area of the annulus was defined as the ring of the initial aortic valve prosthesis. Coronary buttons were measured at their lowest and highest point to define partial or full position below the valve level and the general button size. For assessment of the annular-to-coronary distance, the lower edge of the coronary button was chosen. VTC was assessed after root replacement in patients who had at least one coronary partially under the level of the valve. For this measurement a virtually inserted valve was placed in the bioprosthetic frame. | Other | RR patients, VSRR patients |
Primary outcome
CT-measurement: Aortic annulus area
Time frame: January 2024-June 2024
CT-measurement: Valve-to-coronary distance
Time frame: January 2024-June 2024
CT measurement: Annulus-to-coronary distance
Time frame: January 2024-June 2024
CT-measurement: Size of coronary buttons
Time frame: January 2024-June 2024
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 20 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease Mixed and Transcatheter Aortic Valve Replacement, run by Alicja Zientara 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 2 inclusion and 2 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 20 Nov 2024. 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?
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?
CT-measurement: Aortic annulus area (time frame: January 2024-June 2024). The study lists 4 primary outcomes in all. 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 20 Nov 2024.