Echocardiography Guided TAVR (Echo TAVR)

NCT07030062 | Recruiting DMC

• 1 other identifier: 2025-2621
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Replacemen; Echocardiography

Outcome Measures

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

  30-day after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pan Xiangbin: lead

Study Sites (1)

Fuwai Hospital

Beijing, 100037, China

RECRUITING

Central Study Contacts

Xiangbin Pan, MD

CONTACT

88396655; panxiangbin@fuwaihospital.org

Fengwen Zhang, MD

CONTACT

88396654

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: February 18, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CN (1)