Transcatheter Aortic Valve ReplacementSENSE-ARNCT05737264
TAVR in Adults With Pure Severe Aortic Regurgitation
An observational study of Transcatheter Aortic Valve Replacement and Aortic Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Aortic Regurgitation
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe aortic regurgitation undergo transcatheter aortic valve replacement in medical centers
Who may be able to join
- Age ≥ 60 years;
- Patients with severe aortic regurgitation (> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width > 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2
- TAVR has been performed;
- Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up.
Who cannot join
- History of aortic valve replacement;
- Combined with moderate-severe mitral regurgitation and moderate aortic stenosis;
- Acute endocarditis or other acute cardiac inflammation;
- Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent);
- Other conditions judged by the investigator as not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510123
yanren peng, +86 15626278694, suoxinsuo@gmail.com
About this study
Official title: Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Regurgitation, Observational
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAVR group | The group that undergoes transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Death caused by any reason
Measured: 12 months
Disabling stroke
Stroke that results in a disabled state
Measured: 12 months
Rehospitalization for heart failure
Rehospitalization for heart failure
Measured: 12 months
Secondary outcomes (6)
Device success
Absence of procedural mortality AND Correct positioning of a single prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (no prosthesis- patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Measured: intraoperative
Perioperative complications
Perioperative complications conclude Life-threatening bleeding, Acute kidney injury-Stage 2 or 3 (including renal replacement therapy), Coronary artery obstruction requiring intervention, Major vascular complications, and Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
Measured: up to 1 week
New permanent pacemaker implantation(PPI)
New PPI indications:
- persistent high-degree AV block
- sick sinus syndrome
Measured: up to 1 week
New complete left bundle branch block(CLBBB)
Diagnostic criteria are defined as follows:
- Rhythm must be of super-ventricular origin (EG: ventricular activation coming from atrial or AV nodal activation)
- QRS Duration greater than 120 ms
- Lead V1 should have either a QS or a small r wave with large S wave
- Lead V6 should have a notched R wave and no Q wave.
Measured: up to 1 week
Valve-related dysfunction
Mean aortic valve gradient ≥20 mmHg, EOA ≤0.9-1.1 cm and DVI <0.35 m/s, and/or moderate or severe prosthetic valve regurgitation, and/or Prosthetic valve endocarditis, and/or Prosthetic valve thrombosis
Measured: 12 months
NYHA class Ill or IV
The New York Heart Association (NYHA) class Ill or IV
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Dec 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (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 ReplacementStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 76 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737264
- Sponsor's protocol ID
- SYSKY-2022-518-01
- Acronym
- SENSE-AR
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transcatheter Treatment of Severe Native Aortic Regurgitation With Self-Expandable Valve Implantation: a Multicenter, Observational,Cohort Study(SENSE-AR)
- ClinicalTrials.gov ID
- NCT05737264
- Acronym / sponsor ID
- SENSE-AR / SYSKY-2022-518-01
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Regurgitation, Observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 21 Feb 2023 (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.
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR group | – | –The group that undergoes transcatheter aortic valve replacement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe aortic regurgitation undergo transcatheter aortic valve replacement in medical centers
Key inclusion criteria (4 listed)
- Age ≥ 60 years;
- Patients with severe aortic regurgitation (> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width > 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2
- TAVR has been performed;
- Patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up.
Key exclusion criteria (5 listed)
- History of aortic valve replacement;
- Combined with moderate-severe mitral regurgitation and moderate aortic stenosis;
- Acute endocarditis or other acute cardiac inflammation;
- Allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent);
- Other conditions judged by the investigator as not suitable for the study
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
all-cause mortality
Time frame: 12 months
Death caused by any reason
Disabling stroke
Time frame: 12 months
Stroke that results in a disabled state
Rehospitalization for heart failure
Time frame: 12 months
Rehospitalization for heart failure
6 secondary outcomes
Device success
Time frame: intraoperative
Perioperative complications
Time frame: up to 1 week
New permanent pacemaker implantation(PPI)
Time frame: up to 1 week
New complete left bundle branch block(CLBBB)
Time frame: up to 1 week
Valve-related dysfunction
Time frame: 12 months
NYHA class Ill or IV
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
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Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
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Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
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. This study is not recruiting at the moment.
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 Replacement and Aortic Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ruqiong nie (+86 13600479016, nieruqiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 12 months). The study lists 3 primary outcomes in all. 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 30 May 2023.