Transcatheter Aortic Valve ReplacemenNCT07030062
Echocardiography Guided TAVR (Echo TAVR)
An observational study of Transcatheter Aortic Valve Replacemen and Echocardiography, run by Pan Xiangbin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transcatheter Aortic Valve Replacemen, Echocardiography
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 31 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fengwen Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, 100037
Xiangbin Pan, MD, 88396655, panxiangbin@fuwaihospital.org
About this study
Official title: Transcatheter Aortic Valve Replacement With Echocardiography Guidance
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30-day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start18 Feb 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ReplacemenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Pan Xiangbin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030062
- Sponsor's protocol ID
- 2025-2621
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Replacement With Echocardiography Guidance
- ClinicalTrials.gov ID
- NCT07030062
- Acronym / sponsor ID
- 2025-2621
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pan XiangbinUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fengwen Zhang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Replacemen and Echocardiography, run by Pan Xiangbin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangbin Pan, MD (88396655, panxiangbin@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve Academic Research Consortium-3 (VARC-3) (time frame: 30-day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.