Aortic Valve StenosisTAVINCT06154642
Perioperative Hemodynamic and Microcirculatory Physiological Study During TAVI
An observational study of Aortic Valve Stenosis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor and Skin temperature gradient
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 May 2024to 13 Jul 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: Selection from patients with severe aortic stenosis referred to the Geneva tertiary university hospital for minimally invasive procedures.
Who may be able to join
- All major patients undergoing a femoral TAVI procedure for severe aortic stenosis,
Who cannot join
- Non-femoral approach for TAVI implantation,
- Presence of other concomitant severe valve disease,
- Planned procedure under general anesthesia,
- Anticipated inability to perform a 6-minute walk test post-operatively (physical handicap),
- Heart failure with left ventricular ejection fraction <40%,
- Chronic end-stage renal failure,
Show all 11Show fewer
- Chronic lung disease with home oxygen therapy,
- Acquired changes in serum VEGF levels: recent myocardial infarction or stroke, recent vascular intervention (< 3 months), active cancer, anti-angiogenic immunotherapy,
- Patients with known or identified cognitive disorders,
- Persons deprived of their liberty, persons under protective supervision,
- Pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Study of Hemodynamic and Microcirculatory Evolution Before/After Transcatheter Aortic Valve Replacement (TAVI)
The Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. The hypothesis of the study is that adaptive microcirculatory phenomena occur during TAVI implantation. The results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after TAVI. There is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after TAVI. Early features of this adaptation are associated with the occurrence of short- and medium-term complications.
Read the detailed description
This is a prospective, physiologic, monocentric, pilot cohort study carried out at the University Hospitals of Geneva on the initiative of the investigator. We are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. In addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. The clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Determination of arterial compliance using blood pressure waveform analysis, Measurement of plasma Vascular Endothelium Growth Factor, Skin temperature gradient, Vaso-occlusion test, Transthoracic echocardiography
- Keywords
- Transcatheter Aortic Valve Implantation, Microcirculation, Endothelium, vascular, Microvascular reactivity
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of arterial compliance using blood pressure waveform analysisDiagnostic test
Also called Arterial tonometry
Measurement of arterial stiffness using a non-invasive pressure transducer placed on the skin of the wrist, which records the pulse wave at the level of the radial artery in order to analyze the characteristics of the arterial wall. The parameters of interest are the arterial stiffness of large- and small-caliber arteries (ml/mmHg).
Measurement of plasma Vascular Endothelium Growth FactorDiagnostic test
Also called Vascular Endothelium Growth Factor
Measurement of plasma Vascular Endothelium Growth Factor levels by ELISA
Skin temperature gradientDiagnostic test
Also called Forearm-to-fingertip temperature gradient
Measurement of skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip)
Vaso-occlusion testDiagnostic test
Also called Reactive hyperemia
Measurement of endothelial function by a vaso-occlusion test performed by inflating a cuff on the arm to occlude arterial flow for 3 min. Reactive hyperemia on deflation of the cuff is measured by photoplethysmography placed on the index finger, and tissue oxygen saturation (StO2) by near-infrared spectroscopy (NIRS). The amplitude of the reperfusion flow corresponding to the peak of the perfusion index (ΔPI Peak) and the time to reach this peak (time to peak) are the parameters recorded by photoplethysmography. Tissue resaturation rate (rStO2) is the parameter recorded by NIRS.
Transthoracic echocardiographyDiagnostic test
The diameter of the left ventricular outflow tract is measured in the tele systolic parasternal long-axis view. The pulsed Doppler flow profile is acquired at the level of the left ventricular chamber in the apical five-chamber view. The time-velocity integral of the aortic flow is then calculated. Left ventricular end-diastolic and end-systolic volumes are also measured using Simpson's method in the 4-cavity monoplane view. Measurements of vena cava diameter and respiratory variability of vena cava diameter provide an estimate of right atrial pressure. These measurements estimate cardiac output and systemic vascular resistance.
PhotoplethysmographyDiagnostic test
Also called Perfusion index
The perfusion index (PI) is derived from the signal and represents the ratio between the absorbance or reflectance of pulsatile and non-pulsatile light of the photoplethysmography signal. PI is measured non-invasively using a photoplethysmographic sensor placed on the earlobe or finger.
Transcatheter aortic valve insertion (TAVI)Procedure or surgery
Also called Transcatheter Aortic Valve Replacement (TAVR)
TAVI is a treatment for aortic valve stenosis. A new valve is inserted with minimally invasive procedure without removing the old, damaged valve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification in arterial stiffness in large- and small-caliber arteries
Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements.
Measured: 24 hours
Modification in plasma Vascular Endothelium Growth Factor levels
Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements.
Measured: 24 hours
Modification in skin surface temperature gradient
Change in skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip)
Measured: 24 hours
Modification in reactive hyperemia
Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (ΔPI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2).
Measured: 24 hours
Secondary outcomes (5)
Organ dysfunction
Organ dysfunction: Composite including one of the following events:
- Acute Kidney Injury (KDIGO classification 1 and above),
- Acute lung injury (measured or estimated arterial oxygen pressure / inspired oxygen fraction ratio <200),
- Postoperative cardiovascular failure (need for vasopressor or inotropic support for more than 2 hours),
- Postoperative neurocognitive impairment assessed using the 3D-Confusion Assessment Method
Measured: 7 days
Functional capacity
Distance covered in a 6-minute walk test and percentage of predicted distance
Measured: day 6
Mortality
All causes mortality
Measured: 30 days
Major Adverse Cardiovascular Events (MACE)
Composite:
- Acute myocardial infarction, unstable angina, postoperative high-sensitivity troponin (≥ 65 ng/L),
- Stroke (including transient),
- Death of cardiovascular origin.
Measured: 30 days
Major Adverse Kidney Events (MAKE)
Composite:
- Dependence on renal replacement therapy,
- Decrease in glomerular filtration rate to <75% of baseline,
- All causes mortality.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start8 May 2024
- Primary completion13 Jun 2024
- Study completion13 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Stanislas Abrard, Noble Stéphane
- Responsible party
- Principal investigator, Karim Bendjelid, University Hospital, Geneva
- Investigators
- Karim Bendjelid, Ph.D., Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154642
- Sponsor's protocol ID
- 2023-01118
- Other IDs
- 2023
- Acronym
- TAVI
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study of Hemodynamic and Microcirculatory Evolution Before/After Transcatheter Aortic Valve Replacement (TAVI)
- ClinicalTrials.gov ID
- NCT06154642
- Acronym / sponsor ID
- TAVI / 2023-01118
- Conditions
- Aortic Valve Stenosis
- Keywords
- Transcatheter Aortic Valve Implantation, Microcirculation, Endothelium, vascular, Microvascular reactivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Stanislas Abrard, Noble Stéphane
- Study start
- 8 May 2024 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jul 2024 (actual)
- First posted
- 4 Dec 2023 (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 Physiological Study of Haemodynamic and Microcirculatory Evolution before/after Transcatheter Aortic Valve Replacement (TAVI) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. The hypothesis of the study is that adaptive microcirculatory phenomena occur during TAVI implantation. The results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after TAVI. There is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after TAVI. Early features of this adaptation are associated with the occurrence of short- and medium-term complications.
Detailed description
This is a prospective, physiologic, monocentric, pilot cohort study carried out at the University Hospitals of Geneva on the initiative of the investigator. We are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. In addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. The clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.
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
- Selection from patients with severe aortic stenosis referred to the Geneva tertiary university hospital for minimally invasive procedures.
Key inclusion criteria (1 listed)
- All major patients undergoing a femoral TAVI procedure for severe aortic stenosis,
Key exclusion criteria (11 listed)
- Non-femoral approach for TAVI implantation,
- Presence of other concomitant severe valve disease,
- Planned procedure under general anesthesia,
- Anticipated inability to perform a 6-minute walk test post-operatively (physical handicap),
- Heart failure with left ventricular ejection fraction <40%,
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 |
|---|---|---|
| Determination of arterial compliance using blood pressure waveform analysisAlso: Arterial tonometryMeasurement of arterial stiffness using a non-invasive pressure transducer placed on the skin of the wrist, which records the pulse wave at the level of the radial artery in order to analyze the characteristics of the arterial wall. The parameters of interest are the arterial stiffness of large- and small-caliber arteries (ml/mmHg). | Diagnostic test | – |
| Measurement of plasma Vascular Endothelium Growth FactorAlso: Vascular Endothelium Growth FactorMeasurement of plasma Vascular Endothelium Growth Factor levels by ELISA | Diagnostic test | – |
| Skin temperature gradientAlso: Forearm-to-fingertip temperature gradientMeasurement of skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip) | Diagnostic test | – |
| Vaso-occlusion testAlso: Reactive hyperemiaMeasurement of endothelial function by a vaso-occlusion test performed by inflating a cuff on the arm to occlude arterial flow for 3 min. Reactive hyperemia on deflation of the cuff is measured by photoplethysmography placed on the index finger, and tissue oxygen saturation (StO2) by near-infrared spectroscopy (NIRS). The amplitude of the reperfusion flow corresponding to the peak of the perfusion index (ΔPI Peak) and the time to reach this peak (time to peak) are the parameters recorded by photoplethysmography. Tissue resaturation rate (rStO2) is the parameter recorded by NIRS. | Diagnostic test | – |
| Transthoracic echocardiographyThe diameter of the left ventricular outflow tract is measured in the tele systolic parasternal long-axis view. The pulsed Doppler flow profile is acquired at the level of the left ventricular chamber in the apical five-chamber view. The time-velocity integral of the aortic flow is then calculated. Left ventricular end-diastolic and end-systolic volumes are also measured using Simpson's method in the 4-cavity monoplane view. Measurements of vena cava diameter and respiratory variability of vena cava diameter provide an estimate of right atrial pressure. These measurements estimate cardiac output and systemic vascular resistance. | Diagnostic test | – |
| PhotoplethysmographyAlso: Perfusion indexThe perfusion index (PI) is derived from the signal and represents the ratio between the absorbance or reflectance of pulsatile and non-pulsatile light of the photoplethysmography signal. PI is measured non-invasively using a photoplethysmographic sensor placed on the earlobe or finger. | Diagnostic test | – |
| Transcatheter aortic valve insertion (TAVI)Also: Transcatheter Aortic Valve Replacement (TAVR)TAVI is a treatment for aortic valve stenosis. A new valve is inserted with minimally invasive procedure without removing the old, damaged valve. | Procedure or surgery | – |
Primary outcome
Modification in arterial stiffness in large- and small-caliber arteries
Time frame: 24 hours
Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements.
Modification in plasma Vascular Endothelium Growth Factor levels
Time frame: 24 hours
Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements.
Modification in skin surface temperature gradient
Time frame: 24 hours
Change in skin surface temperature gradient, defined as the difference in temperature between the skin surface of the forearm and that of the fingertip (forearm-to-fingertip)
Modification in reactive hyperemia
Time frame: 24 hours
Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (ΔPI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2).
5 secondary outcomes
Organ dysfunction
Time frame: 7 days
Functional capacity
Time frame: day 6
Mortality
Time frame: 30 days
Major Adverse Cardiovascular Events (MACE)
Time frame: 30 days
Major Adverse Kidney Events (MAKE)
Time frame: 30 days
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 6 Aug 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.
Karim Bendjelid, Ph.D. principal investigator
University Hospital, Geneva
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 Stenosis, run by University Hospital, Geneva 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 1 inclusion and 11 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 6 Aug 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 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?
Modification in arterial stiffness in large- and small-caliber arteries (time frame: 24 hours). 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 6 Aug 2024.