Coronary microvascular dysfunction and heart failure after TAVI

JRCT ID: jRCT1052240127

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aortic stenosis, Heart failure, Coronary microvascular dysfunction
• Date of first enrollment: 09/10/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: CFR and IMR as indicators of coronary microvascular dysfunction before and after TAVI

Secondary Outcome

Evaluation of the correlation between wire-based IMR and angio-based IMR
Transthoracic echocardiography: assessment of the severity of various valvular diseases and left ventricular mass index
Cardiac MRI: assessment of left ventricular mass index and Late Gadolinium Enhancement (LGE)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Adults aged 20 years or older
Patients with severe aortic valve stenosis who are eligible for TAVI treatment and are scheduled for TAVI
Patients with stenosis findings or suspected stenosis on coronary CT prior to TAVI
Cases where informed consent has been obtained from the patient for participation in the study

Exclude criteria

Presence of severe valvular disease (stenosis or regurgitation) other than aortic valve stenosis
Patients who have undergone PCI during the pre-TAVI cardiac catheterization or are scheduled to undergo PCI postoperatively
Patients deemed unsuitable for this study by the principal (or sub-investigator) physician

Related Information

• Primary Sponsor: Nakazawa Gaku
• Secondary Sponsor: Fujita Kosuke