Aortic Valve Stenosis Clinical Trial
— TAVIOfficial title:
Physiological Study of Hemodynamic and Microcirculatory Evolution Before/After Transcatheter Aortic Valve Replacement (TAVI)
Verified date | June 2024 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | July 13, 2024 |
Est. primary completion date | June 13, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All major patients undergoing a femoral TAVI procedure for severe aortic stenosis, Exclusion Criteria: - 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, - 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Prof Karim Bendjelid | Geneve | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Noble Stéphane, Stanislas Abrard |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modification in arterial stiffness in large- and small-caliber arteries | Change in arterial stiffness of large/small caliber arteries between preoperative and postoperative measurements. | 24 hours | |
Primary | Modification in plasma Vascular Endothelium Growth Factor levels | Change in plasma Vascular Endothelium Growth Factor levels between preoperative and postoperative measurements. | 24 hours | |
Primary | 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) | 24 hours | |
Primary | Modification in reactive hyperemia | Change in reactive hyperemia induced by vaso-occlusion test measured by peak of the perfusion index (?PI Peak), the time to reach the peak (time to peak), and the tissue resaturation rate (rStO2). | 24 hours | |
Secondary | 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 |
7 days | |
Secondary | Functional capacity | Distance covered in a 6-minute walk test and percentage of predicted distance | day 6 | |
Secondary | Mortality | All causes mortality | 30 days | |
Secondary | 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. |
30 days | |
Secondary | Major Adverse Kidney Events (MAKE) | Composite:
Dependence on renal replacement therapy, Decrease in glomerular filtration rate to <75% of baseline, All causes mortality. |
30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03186339 -
Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
|
||
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Terminated |
NCT02854319 -
REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System
|
N/A | |
Recruiting |
NCT05601453 -
The ReTAVI Prospective Observational Registry
|
||
Withdrawn |
NCT05481814 -
CPX in Paradoxical Low Flow Aortic Stenosis
|
||
Completed |
NCT02241109 -
Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity
|
N/A | |
Completed |
NCT01700439 -
Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve
|
N/A | |
Recruiting |
NCT04429035 -
SLOW-Slower Progress of caLcificatiOn With Vitamin K2
|
N/A | |
Completed |
NCT04103931 -
Impact of a Patient Decision Aid for Treatment of Aortic Stenosis
|
N/A | |
Completed |
NCT03950440 -
Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
|
||
Active, not recruiting |
NCT02661451 -
Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)
|
N/A | |
Completed |
NCT02792452 -
Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
|
||
Completed |
NCT02758964 -
Evaluation of Cerebral Thrombembolism After TAVR
|
||
Completed |
NCT02847546 -
Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation
|
N/A | |
Not yet recruiting |
NCT02536703 -
Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population
|
Phase 3 | |
Not yet recruiting |
NCT02541877 -
Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve
|
Phase 3 | |
Completed |
NCT02249000 -
BIOVALVE - I / II Clincial Investigation
|
N/A | |
Not yet recruiting |
NCT02221921 -
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
|
N/A | |
Active, not recruiting |
NCT02080299 -
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
|
Phase 2 | |
Terminated |
NCT01939678 -
Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease
|