SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients

NCT05983458 | Recruiting

• 1 other identifier: SAFARI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Recent evidence from scientific literature supported the extension of TAVI procedures to lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk patient populations is still limited by complications and costs, with a large disparity between clinical trials and real-world scenarios suggesting still long hospitalizations after TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with many studies showing a more favourable cost profile associated with early discharges

Conditions

Stenoses, Aortic

Outcome Measures

Primary Outcomes (1)

• safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve

  Primary Endpoints Composite endpoints (VARC 3) Introduction of the composite endpoint of technical success defined at exit from procedure room with: freedom from mortality successful access, delivery of the device, and retrieval of the delivery system correct positioning of a single prosthetic heart valve into the proper anatomical location freedom from surgery or intervention related to the device or to a major vascular or access related, or cardiac structural complication, Expansion of device success composite endpoint at 30 days defined as: Technical Success Freedom from mortality, Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication, Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) Clinical Efficacy composite endpoint now at 1 year and beyond instead of 30 days

  12 months

Study Arms (1)

patients with severe symptomatic aortic stenosis

OTHER

Real-world patients with severe symptomatic aortic stenosis allocated to TAVI treatment by local heart Team will be included in the study according to the inclusion and exclusion criteria specified below.

Procedure: Transaortic valve replacement

Interventions

Transaortic valve replacement PROCEDURE

TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided. For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications. All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.

patients with severe symptomatic aortic stenosis

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Roberto Nerla, MD

  Maria Cecilia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Nerla, MD

CONTACT

0545/217446; rnerla@gvmnet.it

Fausto Castriota, MD

CONTACT

0545/217337; fcastriota@gvmnet.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: August 9, 2023
• Study Start: September 26, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)