Clinical Trials Logo
  1. Home
  2. Aortic Valve Stenosis
  3. NCT04514250

Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients — SAVI-AoS  

Aortic Valve Stenosis Clinical Trial

Official title:
Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients

Clinical Trial Summary

Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with transvalvular flow and might be a better predictor of symptoms and prognosis. The current study will demonstrate the value of SAVI (both non-invasive and invasive) in patients with moderate aortic stenosis. The population will consist of subjects at least 50 years old with moderate aortic stenosis (defined as aortic valve area >1.0 cm2 plus either maximal velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg). Subjects with severe concomitant valve disease or severe unrevascularized coronary artery disease will be excluded, so that the isolated prognosis of aortic stenosis can be investigated. All subjects will undergo invasive SAVI measurements during catheterization. Furthermore patients will receive non-invasive testing with an exercise echocardiogram and computed tomography (CT) scan for non-invasive SAVI measurements. The short-term objective will compare SAVI with standard resting indexes for symptom burden, functional capacity, and biomarkers. The long-term objective will associate SAVI and standard resting indexes with clinical outcomes related to valvular disease. The investigators hypothesize that low SAVI (more marked AS during stress) will track with more symptoms and a worse prognosis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will have several study visits. The index visit will be planned to obtain informed consent and baseline parameters. The measurement visit(s) will consist of the invasive SAVI measurement, echocardiogram, stress echo imaging, 6-minute walk test, quality of life questionnaire, and the cardiac CT. During the final visit after 12 months, subjects will undergo a CT valvular calcium scan, quality of life questionnaire, and 6-minute walk test. Every subject will have an echocardiogram yearly as suggested by guideline criteria and could possibly be contacted until five years after enrollment. Blood samples will be drawn at baseline and the 1-year follow-up. Potentially the new SAVI metric could identify patients at higher risk among those with moderate gradient AS. However, since no outcome data currently exists regarding SAVI and prognosis, no conclusions could be derived from these measurements until study completion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04514250
Study type Observational [Patient Registry]
Source Catharina Ziekenhuis Eindhoven
Contact
Status Active, not recruiting
Phase
Start date April 14, 2021
Completion date October 1, 2028
View Details
See also
  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
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation 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