Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients meeting ALL the following criteria will be included:

• Patients aged ≥ 18 years.

• Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation.

• The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease.

• Heart team decision of VIV procedure.

• Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year.

Locations
Other Locations
Spain
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario de La Paz
RECRUITING
Madrid
Hospital Universitario Puerta De Hierro
RECRUITING
Majadahonda
Hospital Clínico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitari I Politècnic de La Fe
RECRUITING
Valencia
United Kingdom
Manchester University NHS Foundation Trust
RECRUITING
Manchester
Freeman Hospital
RECRUITING
Newcastle
Morriston Hospital, Swansea
RECRUITING
Swansea
Contact Information
Primary
RAÚL MORENO GÓMEZ, MD, PhD
raulmorenog@hotmail.com
0034917277000
Backup
FUNDACION EPIC
iepic@fundacionepic.org
0034987876135
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 104
Treatments
Active_comparator: NVT ALLEGRA System TF
NVT ALLEGRA System TF
Experimental: EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov