A Clinical Trial of the Transcatheter Aortic Valve Implantation System With a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients With Severe Aortic Stenosis

NCT05673525 | Not Yet Recruiting

• 1 other identifier: KOKA-2022-03
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial of the Transcatheter Aortic Valve Implantation System with a Prospective, Multi-Center, One-Arm Approach to Evaluate the Efficacy and Safety in the Treatment of Patients with Severe Aortic Stenosis

Conditions

Aortic Stenosis

Keywords

Heart Valve Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  Cumulative all-cause mortality at 12 months postoperatively

  12 months postoperatively

Secondary Outcomes (5)

• Transvalvular Gradient

  30 days and 12 months postoperatively

• Aortic Regurgitation Degree

  30 days and 12 months postoperatively

• Perivalvular Leakage

  30 days and 12 months postoperatively

• Cardiac Function

  30 days and 12 months postoperatively

• Quality of Survival

  30 days and 12 months postoperatively

Study Arms (1)

Treatment Group

EXPERIMENTAL

Device: Transcatheter Aortic Valve Implantation (KOKA-VALVE)

Interventions

Transcatheter Aortic Valve Implantation (KOKA-VALVE) DEVICE

Transcatheter Aortic Valve Implantation

Treatment Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Contraindication to surgery, or high risk for surgery (STS ≥ 8%) as assessed by the heart team; or other circumstances that make surgical valve replacement inappropriate.
• Age ≥65 years.
• Patients with symptomatic severe aortic stenosis (mean aortic transvalvular gradient by echocardiography ≥40 mmHg (1 mmHg=0.133 kPa), or transaortic flow velocity ≥4.0 m/s, or aortic valve orifice area \<0.8 cm2, or effective aortic orifice area index \<0.5 cm2 /m2).
• The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.

You may not qualify if:

• Life expectancy less than 1 year after implantation of the prosthetic valve.
• Patients had an acute heart attack within 1 month, or had a coronary stent or a pacing device implantation within 1 month, or had any therapeutic cardiac surgery within 1 month.
• Patients with aortic root anatomy and lesion that are not suitable for prosthetic valve implantation.
• Combined with severe insufficiency or stenosis of other valves and requiring surgical treatment.
• Hematologic cachexia, including leukopenia (WBC \<3×10\^9 /L), acute anemia (HB \<90 g/L), thrombocytopenia (PLT \<50 × 10\^9 /L), bleeding constitution, and coagulation disorders.
• Untreated coronary artery disease requiring hematologic reconstruction.
• Hypertrophic obstructive cardiomyopathy.
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20%.
• Severe right ventricular insufficiency.
• The existent of intracardiac masses, thrombi or superfluous organisms by echocardiography.
• Patients who cannot tolerate anticoagulation or antiplatelet therapy.
• Patients had cerebrovascular event (CVA), including ischemic stroke and hemorrhagic stroke within 3 months.
• Decompensation of renal insufficiency.
• Active infective endocarditis or other active infection.
• Untreated conduction system disease requiring pacemaker implantation.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Structral Heart Disease Center, Fuwai Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Cardiovascular Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Xiangbin Pan

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunrui Xiang

CONTACT

+86 17601425727; crxiang@kokalife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Structural Heart DiseaseAffiliation

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 6, 2023
• Study Start: December 30, 2022
• Primary Completion: December 30, 2024
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)