Aortic Stenosis - Prognosis, Risk and Outcomes
ConditionAortic Stenosis Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVastra Gotaland Region
About this trial
The investigators will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital, which is the second largest TAVI hospital in Sweden. Eligible patients should have a clinical indication for aortic valve replacement with TAVI and have preprocedural clinical investigations with echocardiography (UCG) and CCT and provide written informed consent. UCG, electrocardiogram (ECG) and blood samples will be taken in addition to clinical status, NYHA-class and collection of outcome events the day before the procedure, 1±2 hours, 24 ±6hours and daily after the procedure until discharged from Sahlgrenska. Further follow-up will be scheduled day 14, 30, 180, 365 and yearly. Cardiac MRI will be performed before, at 14 days and at 180 days after TAVI. Brain MRI will be performed before and 24± hours after TAVI. Cardiac CT will be performed at 180 days after TAVI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with clinical indication for aortic valve replacement and scheduled for TAVI
Patient willing and able to provide signed informed consent
Disqualifiers
Inability to provide informed consent Additional exclusion criteria for MRI
Estimated glomerular filtration rate <30 ml/kg/min (MRI without contrast can be performed )
Claustrophobia or inability to tolerate confined spaces.
Non-compatible metal device present in body
Trial population
We will prospectively enroll 300 patients undergoing TAVI at Sahlgrenska University Hospital
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: TAVI patients
Trial outcomes
Primary outcomes
1
Cardiac damage
To study change in stage of cardiac damage (stage 0-4) by echocardiography.
Time frame
Baseline and 180 daysSecondary outcomes
1
Change in echocardiography parameters
To study E/é ratio in echocardiography derived parameters indicating cardiac damage (delta%)
Time frame
Baseline and at 14, 30 and 180 days2
Change in echocardiography parameters
To study Left ventricular mass change on echocardiography (delta gram)
Time frame
Baseline and at 14, 30 and 180 days3
Left Atrial -strain
To study change in LA-strain derived by echocardiography (delta %)
Time frame
Baseline and at 14, 30 and 180 days4
Change in echocardiography parameters
To study the influence of effectiv orfice area (cm2)of the aortic valve on cardiac damage (stage 0-4)
Time frame
Baseline and at 14, 30 and 180 daysSponsors and contacts
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Source ClinicalTrials.gov