Atrioventricular Annular CalcificationNCT05275088

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

A study testing Prizvalve® system in people with Atrioventricular Annular Calcification and Failed Prosthetic Atrioventricular Valve/ Annulus Repair, run by Shanghai NewMed Medical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair
What is being tested?: Prizvalve® system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 9 Mar 2022to 10 Jun 2028
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
Patient with hypertrophic cardiomyopathy with obstruction;
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
Echocardiographic evidence of intracardiac mass, thrombus or vegetation;

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Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;
Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;
Active stage of infective endocarditis or other active infection;
Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;
Patient with poor compliance and could not complete the study as required.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Wang chunsheng, Chief, (86)021-64041990 ext. 2512, cswang@medmail.com.cn
Recruiting

Other trials in China

About this study

Official title: An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Read the detailed description

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Conditions: Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Being tested: Prizvalve® system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prizvalve® systemDevice
Transcatheter atrioventricular valve replacement

Study groups in NCT05275088
Study group	Role	What they receive
Treatment	Experimental	Transcatheter atrioventricular valve replacement with the Prizvalve® system Receives: Device: Prizvalve® system

What is being measured

The primary outcome is the main question the study is designed to answer.

Technical success
Definition:
1. Freedom from death;
2. Successful vascular delivery and retrieval of transcatheter valve delivery system;
3. Correct position of transcatheter valve;
4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related);
5. Adequate performance of prosthesis (mean pressure gradient (MVG) <10mmHg, valve regurgitation <2+).
Measured: 30 days

Secondary outcomes (3)

Procedural Success
1. Device success;
2. No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Measured: 30 days,1 year
Device success
Definitions:
1. Freedom from stroke;
2. Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis);
3. No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related);
4. No atrioventricular valve stenosis (mean pressure gradient <10mmHg);
5. Atrioventricular valve regurgitation <2+ (including central leakage and paravalvular leakage), and no related hemolysis;
6. LVOT pressure gradient increased <20mmHg.
Measured: 30 days,1 year
All-cause mortality
All-cause mortality included cardiac and non-cardiac death.
Measured: 30 days,1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202210 Jun 2028

First posted11 Mar 2022
Study start9 Mar 2022
Primary completionMar 2024 (estimated)
Study completion10 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Atrioventricular Annular CalcificationStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05275088
Sponsor's protocol ID: P-valve-2021-12
Status last verified: Nov 2023
First submitted: 25 Feb 2022
Last updated: 18 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair
ClinicalTrials.gov ID: NCT05275088
Acronym / sponsor ID: P-valve-2021-12
Conditions: Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Shanghai Zhongshan Hospital
Study start: 9 Mar 2022 (actual)
Primary completion: Mar 2024 (estimated)
Study completion: 10 Jun 2028 (estimated)
First posted: 11 Mar 2022 (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.

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Detailed description

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: Prizvalve® systemTranscatheter atrioventricular valve replacement with the Prizvalve® system

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (11 listed)

Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
Patient with hypertrophic cardiomyopathy with obstruction;
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;

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
Prizvalve® systemTranscatheter atrioventricular valve replacement	Device	Treatment

Primary outcome

Technical success
Time frame: 30 days
Definition: 1. Freedom from death; 2. Successful vascular delivery and retrieval of transcatheter valve delivery system; 3. Correct position of transcatheter valve; 4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); 5. Adequate performance of prosthesis (mean pressure gradient (MVG) <10mmHg, valve regurgitation <2+).

3 secondary outcomes

Procedural Success
Time frame: 30 days,1 year
Device success
Time frame: 30 days,1 year
All-cause mortality
Time frame: 30 days,1 year

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 18 Nov 2023.

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.

Zhongshan Hospital

Shanghai, China

(86)021-64041990 ext. 2512

cswang@medmail.com.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 0 inclusion and 11 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 18 Nov 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275088.

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 18 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.