Severe and Symptomatic Aortic StenosisNCT03865043
Vascular Complications and Bleeding After Transfemoral TAVI
An observational study of Severe and Symptomatic Aortic Stenosis and Undergoing TAVI, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe and Symptomatic Aortic Stenosis, Undergoing TAVI
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 31 Dec 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: November 2017 at Montpellier University Hospital, France, for severe symptomatic aortic stenosis
Who may be able to join
- Patients undergoing a TAVI at Montpellier University Hospital
- Since November 2017
- With implantation of a COREVALVE or EDWARDS
- By femoral approach
Who cannot join
- Minor patient
- Patient unable to give consent for reasons of understanding or language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Complications and Bleeding After Transfemoral TAVI: a Comparison Between Surgical and Percutaneous Approaches
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery.
However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results]. No data are available comparing both approaches performed by the same team during the same period.
The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.
Read the detailed description
This prospective monocentric observational study aims to include all patients undergoing TAVI via transfemoral access from November 2017 at Montpellier University Hospital, France.
All procedures are performed in the same site by 7 medical teams including 4 different surgeons and 9 interventional cardiologists.
All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and are deemed for TAVI after heart team decision.
Before the procedure, a multislice computerized tomography (MSCT) is systematically performed to evaluate the aortic annulus, the aorta and to determine the access site.
The choice of percutaneous or surgical is at operators' discretion, according to predictable access site difficulties (calcifications, tortuosity femoral bifurcation height) and global considerations as obesity.
Both procedures are performed during the same period, our center using both techniques in a common way.
TAVI procedure are performed under general anesthesia in the majority of cases.
Percutaneous approach The anterior wall of the common femoral artery are punctured under echographic guidance after selection of a site free of calcifications and above the femoral bifurcation and a 6-French sheath was inserted.
Two Perclose ProGlide® devices (Abbott Vascular, Santa Clara, CA) are used to perform the perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed and the nodes from the two previously placed ProGlide® devices were tightened. Final femoral angiographic control is not systematic.
Surgical approach A surgical equivalent of the " preclose technique ", untitled the " zip technique " is performed routinely in our center. This technique avoids arterial crossclamping and purse string effect. Briefly, the femoral artery is exposed through a transversal groin incision, the anterior wall of the artery is cleaned from surrounding tissues up to a few centi- meters. The most suitable site is chosen free of calcifications allowing a puncture and insertion of a 6-French sheath. At the end of the procedure, both ends of the sutures are gently pulled to obtain coaptation of the arterial wall.
Study endpoints The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification.
Secondary end points included complications after TAVI, amount of contrast, amount of radiation, procedure duration, hospitalization length.
Data assessment Data on patients' baseline characteristics, procedural details and in-hospital outcomes is collected from a prospective TAVI database.
No additional testing or biological samples were specifically required for this study.
- Keywords
- TAVI, preclosing
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular complications and bleeding
The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification
Measured: 1 day (at the end of hospitalization)
Secondary outcomes (5)
Other complications after TAVI
Other complications after TAVI
Measured: 1 day (at the end of hospitalization)
amount of radiation
amount of radiation
Measured: 1 day (at the end of hospitalization)
amount of contrast
amount of contrast
Measured: 1 day (at the end of hospitalization)
procedure duration
procedure duration
Measured: 1 day (at the end of hospitalization)
hospitalization length
hospitalization length
Measured: 1 day (at the end of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Symptomatic Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence LECLERCQ, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865043
- Sponsor's protocol ID
- RECHMPL18_0486
- Status last verified
- Mar 2020
- First submitted
- 5 Mar 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Complications and Bleeding After Transfemoral TAVI: a Comparison Between Surgical and Percutaneous Approaches
- ClinicalTrials.gov ID
- NCT03865043
- Acronym / sponsor ID
- RECHMPL18_0486
- Keywords
- TAVI, preclosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 Mar 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.
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery.
However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results]. No data are available comparing both approaches performed by the same team during the same period.
The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.
Detailed description
This prospective monocentric observational study aims to include all patients undergoing TAVI via transfemoral access from November 2017 at Montpellier University Hospital, France.
All procedures are performed in the same site by 7 medical teams including 4 different surgeons and 9 interventional cardiologists.
All patients have severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and are deemed for TAVI after heart team decision.
Before the procedure, a multislice computerized tomography (MSCT) is systematically performed to evaluate the aortic annulus, the aorta and to determine the access site.
The choice of percutaneous or surgical is at operators' discretion, according to predictable access site difficulties (calcifications, tortuosity femoral bifurcation height) and global considerations as obesity.
Both procedures are performed during the same period, our center using both techniques in a common way.
TAVI procedure are performed under general anesthesia in the majority of cases.
Percutaneous approach The anterior wall of the common femoral artery are punctured under echographic guidance after selection of a site free of calcifications and above the femoral bifurcation and a 6-French sheath was inserted.
Two Perclose ProGlide® devices (Abbott Vascular, Santa Clara, CA) are used to perform the perpendicular preclosing. After the deployment of the prosthesis, the TAVI sheath is removed and the nodes from the two previously placed ProGlide® devices were tightened. Final femoral angiographic control is not systematic.
Surgical approach A surgical equivalent of the " preclose technique ", untitled the " zip technique " is performed routinely in our center. This technique avoids arterial crossclamping and purse string effect. Briefly, the femoral artery is exposed through a transversal groin incision, the anterior wall of the artery is cleaned from surrounding tissues up to a few centi- meters. The most suitable site is chosen free of calcifications allowing a puncture and insertion of a 6-French sheath. At the end of the procedure, both ends of the sutures are gently pulled to obtain coaptation of the arterial wall.
Study endpoints The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification.
Secondary end points included complications after TAVI, amount of contrast, amount of radiation, procedure duration, hospitalization length.
Data assessment Data on patients' baseline characteristics, procedural details and in-hospital outcomes is collected from a prospective TAVI database.
No additional testing or biological samples were specifically required for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- November 2017 at Montpellier University Hospital, France, for severe symptomatic aortic stenosis
Key inclusion criteria (4 listed)
- Patients undergoing a TAVI at Montpellier University Hospital
- Since November 2017
- With implantation of a COREVALVE or EDWARDS
- By femoral approach
Key exclusion criteria (2 listed)
- Minor patient
- Patient unable to give consent for reasons of understanding or language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular complications and bleeding
Time frame: 1 day (at the end of hospitalization)
The primary endpoint of our study is a composite of vascular complications and bleeding defined by the modified VARC-2 classification
5 secondary outcomes
Other complications after TAVI
Time frame: 1 day (at the end of hospitalization)
amount of radiation
Time frame: 1 day (at the end of hospitalization)
amount of contrast
Time frame: 1 day (at the end of hospitalization)
procedure duration
Time frame: 1 day (at the end of hospitalization)
hospitalization length
Time frame: 1 day (at the end of hospitalization)
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 10 Mar 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Florence LECLERCQ principal investigator
University Hospital, Montpellier
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 Severe and Symptomatic Aortic Stenosis and Undergoing TAVI, run by University Hospital, Montpellier at 1 site in France.
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 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 10 Mar 2020. 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 France. 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?
vascular complications and bleeding (time frame: 1 day (at the end of hospitalization)). 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 10 Mar 2020.