ZEro Pacemaker Implantation Sutureless Aortic Valve Replacement Study

JRCT ID: jRCT1032230138

Registered date:16/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Aortic stenosis
• Date of first enrollment: 01/06/2023
• Target sample size: 80
• Study type: Interventional

Intervention(s)

In this study, a new implantation protocol for aortic valve replacement using a sutureless bioprosthetic valve for aortic stenosis (or aortic stenosis and regurgitation) consisting of visual confirmation of the position of the prosthetic valve and the membranous septum and displacement of the membranous septum toward the left ventricular side (even if there is no problem with confirmation of the prosthetic valve position and the procedure is terminated) is applied, (This protocol includes cases in which there is no problem with the positioning of the prosthetic valve and the implantation is terminated as is. The implantation protocol consists of the following elements
1) Endoscopic visual confirmation of the position of the prosthetic valve and the membranous septum after placement of the stentless bioprosthetic valve. If the membranous septum can be seen on the left ventricular side of the prosthetic valve stent, it is assumed that there is no mechanical pressure on the inferior border of the membranous septum and post-dilation with a balloon is performed. If the entire septum is hidden by the stent of the prosthetic valve, it is judged that the prosthetic valve is deeply implanted and the inferior border of the membranous septum is under pressure, and the procedure described in 2), membrane septal displacement, is performed.
2) Displace the position of the membranous septum toward the left ventricular side in relation to the prosthetic valve after placement of the soucheress bioprosthetic valve. A forceps is used to tilt the stent at the right coronary apex-uncinate commissure inward to release pressure (Figure 1) while another forceps is used to push down the interventricular triangle at the top of the membranous septum toward the left ventricular side (Figure 2). This procedure again confirms endoscopically that the membranous septum is visible on the left ventricular side of the prosthetic valve, and post-dilation with a balloon is performed. The primary outcome of this protocol will be the implementation of permanent pacemaker implantation at 30 days after the procedure, and whether it is below the threshold (pacemaker implantation rate with a soucheless bioprosthetic valve) set based on the results of previous studies will be verified. At the same time, we will examine the frequency of procedure-related adverse events (perivalvular tissue injury, incidence of reimplantation due to prosthetic valve migration) to verify the safety of the procedure. The 12-lead ECGs will be collected preoperatively, 7 days postoperatively, and 30 days postoperatively, and in patients who require a permanent pacemaker implantation, the 12-lead ECG used to determine the pacemaker indication will be collected, and an independent core laboratory in the Juntendo School of Medicine will analyze and evaluate the occurrence of new conduction defects and causes of pacemaker implantation in the postoperative period. The causes of new stimulating conduction system disturbances and pacemaker implantation after the procedure will be analyzed and evaluated.

Outcome(s)

• Primary Outcome: Implementation of permanent pacemaker implantation up to 30 days postoperatively (including reason, timing, and model of implantation)

Secondary Outcome

1) New atrioventricular block (2nd or 3rd degree) and left bundle branch block at 30 days postoperatively
2) Intraoperative membranous septal injury
3) Re-implantation of prosthetic valve due to migration of the Scherless bioprosthetic valve
4) Periprosthetic regurgitation (zero, trivial, mild, moderate, severe) assessed by transthoracic echocardiogram before discharge

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients undergoing aortic valve replacement using the Perceval bioprosthetic valve for aortic stenosis or aortic stenosis cum regurgitation at institutions participating in this study will be eligible.

Selection Criteria
(1) Age 18 years or older at the time of consent
(2) Patients with aortic valve disease that can be treated with the commercially available Perceval bioprosthetic valve as determined by preoperative CT scan or transesophageal echocardiography.
3) Patients who are judged to be suitable for Perceval bioprosthetic valve based on their age, general condition, and comorbidities.
(iv) Patients who are eligible for 30-day postoperative follow-up
(5) Patients who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the study.

Exclude criteria

Exclusion Criteria
(1) Patients undergoing concomitant surgery other than coronary artery bypass surgery
(2) Patients undergoing preoperative pacemaker (including implantable cardioverter defibrillator) implantation
(3) Patients with a preoperative diagnosis of chronic atrial fibrillation or atrioventricular block of two or more degrees
(4) Patients with a contraindication to Perceval bioprosthetic valve treatment in the package insert
(5) Patients with congenital bicuspid aortic valve (Sievers type 0) or unicuspid aortic valve
(6) Patients with aortic aneurysm or dissection of the ascending aorta
(vii) Patients with active endocarditis, myocarditis, or sepsis
(viii) If the subject is already participating in another clinical trial that may confound the results of this study
(ix) Other cases in which the principal investigator determines that the subject is inappropriate as a research subject.

Related Information

• Primary Sponsor: Tabata Minoru
• Source(s) of Monetary Support: Corcym SRL