Aortic StenosisNCT04160624
Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support
A study testing transcatheter aortic valve replacement in people with Aortic Stenosis and Aortic Regurgitation, run by Xijing Hospital at 1 site in China.
Trial summary
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency. The investigators aim to discuss the clinical efficacy of extracorporeal life support system(ECLS) during TAVR procedure in severe aortic lesion… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Aortic Stenosis, Aortic Regurgitation, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- transcatheter aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Dec 2020
- Phase
- Interventional
- 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 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age of patient is ≥50 yrs;
- Severe aortic stenosis or regurgitation patients (The area of central regurgitation exceeds 40% of left ventricular area; regurgitant volume ≥10ml；EROA≤1.0cm2; PGmean≥50mmHg (Satisfy any condition).
- Small incision surgery of chest can be tolerated.
- General anesthesia is tolerable
- 4. The subject was informed of the clinical application nature of the technology and agreed to participate in all requirements of the clinical application of the new technology, signed the informed consent and agreed to complete.
Who cannot join
- Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
- Subjects with active endocarditis or rheumatic mitral valve disease.
- Life expectancy <1 year for cardiac or other malignant tumors.
- Participate in other clinical trial.
- In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi, 710032
Jian Yang, M.D. Ph.D., +8613892828016, yangjian@fmmu.edu.cn
Jiayou Tang, M.D. Ph.D., +8615353618121, tjy-heart@outlook.com
About this study
Official title: The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic Stenosis/Regurgitation Patients
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency. The investigators aim to discuss the clinical efficacy of extracorporeal life support system(ECLS) during TAVR procedure in severe aortic lesion under very low ejection fraction (EF).
Read the detailed description
Transcatheter aortic valve replacement (TAVR), characterized by minimal invasion, no need for thoracotomy and extracorporeal circulation and definite mid- and long-term efficacy, has been recognized as an effective alternative replacing valve replacement through conventional thoracotomy for senile aortic valve stenosis. However, there are still a large number of patients whose left ventricular ejection fraction (LVEF) significantly declines due to the long history of disease and long-term heart injury, entering the decompensation stage. TAVR will still lead to such severe complications as intraoperative hemodynamic collapse and malignant arrhythmia in these patients, greatly increasing the mortality rate. It is pointed out in the American Heart Association Guideline (2017) that TAVR is not recommended as a treatment means for patients with very poor cardiac function under EF <20%. After conservative medication, the prognosis of patients with aortic valve stenosis under very low EF is poor with a 3-year mortality rate above 85%, and the prognosis after heart transplantation remains controversial. According to the pathological basis of patients and preoperative results of dobutamine test, the cardiac systolic function of some patients is expected to be significantly improved after removal of aortic valve stenosis. Therefore, applying extracorporeal life support system, such as extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass (CPB） in the guarantee of cardiopulmonary function during perioperative period of TAVR is considered as the optimal surgical strategy for such patients.
- Being tested
- transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter aortic valve replacementProcedure or surgery
Also called extracorporeal life support system, extracorporeal membrane oxygenation, cardiopulmonary bypass
Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS
| Study group | Role | What they receive |
|---|---|---|
| Non-ECLS GROUP | Active comparator | For AS/R patients with normal EF, only TAVR was performed Receives: Procedure: transcatheter aortic valve replacement |
| ECLS GROUP | Experimental | For AS/R patients with low EF, TAVR under ECLS-assisted was performed Receives: Procedure: transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiac event
Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery
Measured: 1 year
Secondary outcomes (1)
minor adverse event
Include by limited to: perivalvular regurgitation, infection, arrhythmia, Peripheral vascular complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Aug 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- ECLS-assisted TAVR for patients with very low EF(\<20%). Only TAVR for patients with fair EF(\>20%)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Yang, Xijing Hospital
- Investigators
- Shiqiang Yu, M.D. PH.D., Principal investigator, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160624
- Sponsor's protocol ID
- xjyyxwk002
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support to Cure Aortic Stenosis/Regurgitation Patients
- ClinicalTrials.gov ID
- NCT04160624
- Acronym / sponsor ID
- xjyyxwk002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 Nov 2019 (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.
Transcatheter aortic valve replacement (TAVR) has a high risk and a high mortality rate in the treatment of aortic stenosis/regurgitation patients with cardiac insufficiency. The investigators aim to discuss the clinical efficacy of extracorporeal life support system(ECLS) during TAVR procedure in severe aortic lesion under very low ejection fraction (EF).
Detailed description
Transcatheter aortic valve replacement (TAVR), characterized by minimal invasion, no need for thoracotomy and extracorporeal circulation and definite mid- and long-term efficacy, has been recognized as an effective alternative replacing valve replacement through conventional thoracotomy for senile aortic valve stenosis. However, there are still a large number of patients whose left ventricular ejection fraction (LVEF) significantly declines due to the long history of disease and long-term heart injury, entering the decompensation stage. TAVR will still lead to such severe complications as intraoperative hemodynamic collapse and malignant arrhythmia in these patients, greatly increasing the mortality rate. It is pointed out in the American Heart Association Guideline (2017) that TAVR is not recommended as a treatment means for patients with very poor cardiac function under EF <20%. After conservative medication, the prognosis of patients with aortic valve stenosis under very low EF is poor with a 3-year mortality rate above 85%, and the prognosis after heart transplantation remains controversial. According to the pathological basis of patients and preoperative results of dobutamine test, the cardiac systolic function of some patients is expected to be significantly improved after removal of aortic valve stenosis. Therefore, applying extracorporeal life support system, such as extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass (CPB） in the guarantee of cardiopulmonary function during perioperative period of TAVR is considered as the optimal surgical strategy for such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- ECLS-assisted TAVR for patients with very low EF(<20%). Only TAVR for patients with fair EF(>20%)
| Arm | Type | Receives |
|---|---|---|
| Non-ECLS GROUP | Active comparator | Procedure: transcatheter aortic valve replacementFor AS/R patients with normal EF, only TAVR was performed |
| ECLS GROUP | Experimental | Procedure: transcatheter aortic valve replacementFor AS/R patients with low EF, TAVR under ECLS-assisted was performed |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age of patient is ≥50 yrs;
- Severe aortic stenosis or regurgitation patients (The area of central regurgitation exceeds 40% of left ventricular area; regurgitant volume ≥10ml；EROA≤1.0cm2; PGmean≥50mmHg (Satisfy any condition).
- Small incision surgery of chest can be tolerated.
- General anesthesia is tolerable
- 4. The subject was informed of the clinical application nature of the technology and agreed to participate in all requirements of the clinical application of the new technology, signed the informed consent and agreed to complete.
Key exclusion criteria (5 listed)
- Subject who are pregnant, lactating or scheduled to pregnant during the period of the clinical new technology.
- Subjects with active endocarditis or rheumatic mitral valve disease.
- Life expectancy <1 year for cardiac or other malignant tumors.
- Participate in other clinical trial.
- In the judgment of the investigator, subjects had poor acceptance of chemotherapy, and they cannot complete the trial as required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter aortic valve replacementAlso: extracorporeal life support system, extracorporeal membrane oxygenation, cardiopulmonary bypassUse Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS | Procedure or surgery | ECLS GROUP, Non-ECLS GROUP |
Primary outcome
major adverse cardiac event
Time frame: 1 year
Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery
1 secondary outcome
minor adverse event
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shiqiang Yu, M.D. PH.D. principal investigator
The First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter aortic valve replacement in people with Aortic Stenosis and Aortic Regurgitation, run by Xijing Hospital 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 5 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 13 Nov 2019. 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 Jian Yang, M.D PH.D (+8613892828016, yangjian@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiac event (time frame: 1 year). 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 13 Nov 2019.