Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support

NCT04160624 | Unknown DMC

• 1 other identifier: xjyyxwk002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 under very low ejection fraction (EF).

Conditions

Aortic Stenosis; Aortic Regurgitation; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac event

  Include by limited to: death, emergency surgery, surgically related stroke, severe bleeding, rehospitalization, redo surgery

  1 year

Secondary Outcomes (1)

• minor adverse event

  1 year

Study Arms (2)

Non-ECLS GROUP

ACTIVE COMPARATOR

For AS/R patients with normal EF, only TAVR was performed

Procedure: transcatheter aortic valve replacement

ECLS GROUP

EXPERIMENTAL

For AS/R patients with low EF, TAVR under ECLS-assisted was performed

Procedure: transcatheter aortic valve replacement

Interventions

transcatheter aortic valve replacement PROCEDURE

Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS

Also known as: extracorporeal life support system, extracorporeal membrane oxygenation, cardiopulmonary bypass

ECLS GROUP; Non-ECLS GROUP

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Interventions

Transcatheter Aortic Valve Replacement; Extracorporeal Membrane Oxygenation; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular 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; Respiratory Therapy; Therapeutics; Extracorporeal Circulation

Study Officials

• Shiqiang Yu, M.D. PH.D.

  The First Affiliated Hospital of Air Force Medicial University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Yang, M.D PH.D

CONTACT

+8613892828016; yangjian@fmmu.edu.cn

Jiayou Tang, M.D PH.D

CONTACT

+8615353618121; tjy-heart@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief surgeon

Model Details: ECLS-assisted TAVR for patients with very low EF(\<20%). Only TAVR for patients with fair EF(\>20%)

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 13, 2019
• Study Start: August 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)