Echocardiography Guided TAVR (Echo TAVR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPan Xiangbin
About this trial
Conventional transcatheter aortic valve replacement (TAVR) relies on fluoroscopic and contrast agents. However, in high-risk patients, exposure to ionizing radiation and contrast agents is contraindicated and undesirable. Echocardiography guidance TAVR can offer a feasible and safer strategy for TAVR.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
symptomatic severe AS determined by echocardiography and Doppler that requiring aortic valve replacement, which is defined as: mean gradient ≥40 mmHg, peak aortic velocity ≥4 m/s, and aortic valve area (AVA) ≤1 cm2 (or an indexed AVA ≤0.6 cm2/m2);
a history of malignancy or a high familial risk of cancer, with refusal to undergo contrast- or radiation-guided procedures;
chronic kidney disease and refuse to receive contrast agents or radiation exposure.
Disqualifiers
None
Trial population
Eligible patients included those with symptomatic severe aortic stenosis confirmed by echocardiography (mean gradient ≥40 mmHg, peak velocity ≥4 m/s, and AVA ≤1 cm² or indexed AVA ≤0.6 cm²/m²), individuals with a history or strong family history of cancer who refused contrast- or radiation-guided procedures, and patients with chronic kidney disease unwilling to receive contrast agents or radiation exposure. Patients were excluded if they required hybrid procedures or other cardiac interventions, were deemed inoperable due to extremely high surgical risk or severe comorbidities, had untreated significant coronary artery disease suitable for revascularization, or had previously undergone aortic valve replacement.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Valve Academic Research Consortium-3 (VARC-3)
VARC3 include but not limited to Mortality (all-cause and cardiovascular) Stroke and transient ischemic attack (TIA) Acute kidney injury Conduction disturbances and permanent pacemaker implantation Bleeding (updated using BARC criteria) Myocardial infarction Vascular access complications Endocarditis
Time frame
30-day after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Pan Xiangbin
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov