Safe and fast discharge using the Acurate valve for low-risk aortic stenosis patients

Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients

This study tests if using the Acurate valve for heart surgery can help low-risk aortic stenosis patients leave the hospital faster and with fewer complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 83 Years
• Sex: All
• Sponsor: Maria Cecilia Hospital (other)
• Locations: 1 site (Cotignola, Ravenna)
• Trial ID: NCT05983458 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the use of the Acurate Neo valve for transcatheter aortic valve implantation (TAVI) in low-risk patients with aortic stenosis. The study aims to determine if this valve can reduce hospital stays and associated costs while maintaining high procedural success rates. It focuses on minimizing complications such as electrical, renal, vascular, or neurological issues that can prolong recovery. By comparing the Acurate valve with other options, the trial seeks to ensure optimal outcomes for patients requiring future coronary access.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 83 with normal heart function and suitable anatomy for transfemoral TAVI.

Not a fit: Patients with severe heart conditions, unsuitable anatomy for the procedure, or those requiring general anesthesia may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to shorter hospital stays and improved quality of life for patients undergoing TAVI.

How similar studies have performed: While the Acurate Neo valve has shown promise in high-risk patients, its effectiveness in low-risk populations is still being evaluated, making this a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Age \>=18 and =\< 83 years
2. Normal PR interval at 12-lead electrocardiogram (ECG)
3. No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block ( AV) blocks at 12-lead ECG
4. eGFR \> 50 ml/min/1.73 m2
5. Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

1. Inability to provide informed consent
2. Not suitable anatomy for transfemoral access
3. Need for general anaesthesia (e.g. hemodynamic instability)
4. Bicuspid aortic valve anatomy
5. Severely impaired left ventricular ejection fraction (LVEF \<35%)
6. At least moderate mitral regurgitation
7. Non-cardiac illness with a life expectancy of less than 1 year
8. Currently participating in another trial before reaching first endpoint.

Where this trial is running

Cotignola, Ravenna

• Maria Cecilia Hospital — Cotignola, Ravenna, Italy (RECRUITING)

Study contacts

• Principal investigator: Roberto Nerla, MD — Maria Cecilia Hospital
• Study coordinator: Roberto Nerla, MD

Conditions: Stenoses, Aortic