Aortic AneurysmNCT04068337
Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement
An observational study of Aortic Aneurysm and Aortic Dissection, run by Triemli Hospital at 1 site in Switzerland.
Trial summary
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection, Endocarditis
- What is being tested?
- Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement
- Type of treatment
- Surgery or procedure
- How many people
- 278 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2018to 1 Aug 2019
- 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 September 2007 till March 2017, we performed 278 aortic root replacements with the Freestyle prosthesis at a single centre in Switzerland. Two groups were identified based on the additional replacement of the hemiarch resulting in 119 patients (HA) and 159 patients without an additional hemiarch replacement (non-HA). Patients with additional valve and coronary artery procedures were included as well. Out of the non-HA group, 7 patients were cannulated through the femoral artery and excluded for further analysis.
Who may be able to join
- all patients after implantation of a biological Medtronic Freestyle root prosthesis in the time frame from November 2007 till April 2017
- elective, urgent and emergency operations on ascending aneurysms, aortic dissections, endocarditis and aortic root pathologies
- combination of other procedures (coronary artery bypass grafting, operations on mitral and tricuspid valve, ablations)
Who cannot join
- refused patient consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement in Various Pathologies: A Retrospective Analysis
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta.
The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers.
Read more
Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement.
The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.
- Being tested
- Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement
- Keywords
- hemiarch replacement, cardiopulmonary bypass, cannulation technique, selective cerebral perfusion
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Endocarditis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacementProcedure or surgery
Aortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically
| Study group | Role | What they receive |
|---|---|---|
| Hemiarch | Patients with Freestyle aortic root implantation receiving a hemiarch replacement by open anastomosis technique with axillary cannulation and antegrade cerebral perfusion Receives: Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement | |
| Non-Hemiarch | Patients with Freestyle aortic root implantation without hemiarch replacement with normal systemic perfusion Receives: Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital mortality
Measured: 30 days after initial operation
Major and minor in-hospital complications
stroke, myocardial infarction, re-operation, pacemaker implantation
Measured: 30 days after initial operation
Valve performance
Mean valve gradient of the implanted root prosthesis
Measured: earliest to longest follow up (longest follow up period of 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2018
- Primary completion1 Mar 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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
- Retrospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicja Zientara, Triemli Hospital
- Investigators
- Alicja Zientara, MD, Principal investigator, Triemli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068337
- Sponsor's protocol ID
- BASEC-Nr. 2018-01227
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freestyle Prosthesis for Aortic Root-replacement With and Without Hemiarch Replacement in Various Pathologies: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT04068337
- Acronym / sponsor ID
- BASEC-Nr. 2018-01227
- Keywords
- hemiarch replacement, cardiopulmonary bypass, cannulation technique, selective cerebral perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 28 Aug 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.
The Freestyle® prosthesis (Medtronic plc, Dublin, Ireland) is a biological, porcine aortic root implanted in various combinations and techniques since the 1990s. The main indication for the choice of this prosthesis is a combined pathology with degenerated aortic valve and additional dilatation of the root often involving the ascending aorta.
The Freestyle® prosthesis is also used in cases of dissection of the ascending aorta with the involvement of the aortic valve, which opens the debate on how far the ascending aorta should be replaced for a sustainable solution with calculable low periprocedural risk. Considering a lower intraoperative risk in the life-threatening situation, an extended resection of the aorta can be avoided and only the aortic root replaced with a piece of ascending aorta. On the contrary, focusing on improved long-term outcome, the technique of total arch replacement in aortic dissection was developed in emergency situations with acceptable results, which, however, were often reproducible only in large, experienced centers.
Apart from the abovementioned options, the technique of proximal arch replacement can provide a tension-free anastomosis. The intention of hemiarch replacement is the attachment of the prosthesis to an aneurysm-free portion of the aortic arch helping to protect against further anastomotic aneurysms and spare the patient complex reoperation or interventional procedures in the future. As a possible drawback of the technique, especially in emergency situations, the potentially prolonged duration of surgery and the need of selective brain perfusion via axillary or carotid artery are discussed increasing the risk of stroke and further major events, which could not be reflected in current literature. However, there is still no convincing evidence of a long-term benefit in terms of re-operation and survival after hemiarch replacement.
The aim of this retrospective analysis was to assess the mid-term outcome of the biological Freestyle® prosthesis in combination with operations on the ascending aorta and the aortic arch with regard to prosthetic performance, reoperations, stroke and death.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiarch | – | Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacementPatients with Freestyle aortic root implantation receiving a hemiarch replacement by open anastomosis technique with axillary cannulation and antegrade cerebral perfusion |
| Non-Hemiarch | – | Procedure: Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacementPatients with Freestyle aortic root implantation without hemiarch replacement with normal systemic perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From September 2007 till March 2017, we performed 278 aortic root replacements with the Freestyle prosthesis at a single centre in Switzerland. Two groups were identified based on the additional replacement of the hemiarch resulting in 119 patients (HA) and 159 patients without an additional hemiarch replacement (non-HA). Patients with additional valve and coronary artery procedures were included as well. Out of the non-HA group, 7 patients were cannulated through the femoral artery and excluded for further analysis.
Key inclusion criteria (3 listed)
- all patients after implantation of a biological Medtronic Freestyle root prosthesis in the time frame from November 2007 till April 2017
- elective, urgent and emergency operations on ascending aneurysms, aortic dissections, endocarditis and aortic root pathologies
- combination of other procedures (coronary artery bypass grafting, operations on mitral and tricuspid valve, ablations)
Key exclusion criteria (1 listed)
- refused patient consent
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 |
|---|---|---|
| Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacementAortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically | Procedure or surgery | Hemiarch, Non-Hemiarch |
Primary outcome
In-hospital mortality
Time frame: 30 days after initial operation
In-hospital mortality
Major and minor in-hospital complications
Time frame: 30 days after initial operation
stroke, myocardial infarction, re-operation, pacemaker implantation
Valve performance
Time frame: earliest to longest follow up (longest follow up period of 10 years)
Mean valve gradient of the implanted root prosthesis
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 28 Aug 2019.
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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.
Alicja Zientara, MD principal investigator
Triemli Hospital
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 Aneurysm and Aortic Dissection, run by Triemli Hospital at 1 site in Switzerland.
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 3 inclusion and 1 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 28 Aug 2019. 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 Switzerland. 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?
In-hospital mortality (time frame: 30 days after initial operation). The study lists 3 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 28 Aug 2019.