Transcatheter Aortic Valve Replacement With Echocardiography Guidance
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Valve Academic Research Consortium-3 (VARC-3)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Required hybrid procedures or concomitant interventions on other cardiac malformations; Deemed inoperable due to extremely high surgical risk or severe comorbidities; Had untreated clinically significant coronary vascular disease amenable to revascularization; Previously undergone aortic valve replacement.
Outcomes
Primary Outcomes
Valve Academic Research Consortium-3 (VARC-3)
Time Frame: 30-day after surgery
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Pan Xiangbin
Principle Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital