SPAnish Aortic VALVE Multicentric Study

NCT03595423 | Unknown

• 1 other identifier: SPAVALVE
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there is an increase in the use of bioprosthesis worldwide (\> 70% according to national data of the Spanish Society of Thoracic and Cardiovascular Surgery). There is conflicting evidence regarding the long-term survival of patients aged 50-65 years with mechanical (M) or biological (B) aortic prostheses. General consensus of greater complications associated with the use of long-life anticoagulation in M and of reoperation in B. Similar survival with lower MACCE complications in bioprosthesis could reconsider their choice in patients aged 50-65 years, specially in the current TAVI era. The investigators are going to perform a multicentric retrospective observational study (Registry) about 15 year-outcomes Following Bioprosthetic vs Mechanical Isolated Aortic Valve Replacement for Aortic Stenosis in Patients Aged 50 to 65 Years in 30 Cardiovascular Surgery Centers in Spain

Conditions

Survival, Prosthesis; Prosthesis Durability; Valve Heart Disease

Keywords

long-term survival; bioprosthesis

Outcome Measures

Primary Outcomes (2)

• Number of participants alive

  Survival since surgery

  From date of surgery until the date of death from any cause, assessed up to 18 years

• Late postoperative combined endpoint of 4 Major Adverse Cardiovascular Events (MACE) complications

  Early 30-day Mortality, major bleeding, stroke and need of any prosthesis reoperation

  From date of surgery until the date of first documented MACE (see description) or date of death from any cause, whichever came first, assessed up to 18 years

Secondary Outcomes (3)

• Cumulative incidence of stroke at 15 years between groups

  From date of surgery until the date of first documented stroke or date of death from any cause, whichever came first, assessed up to 18 years

• Cumulative incidence of prosthesis reoperation at 15 years between groups

  From date of surgery until the date of first documented reoperation or date of death from any cause, whichever came first, assessed up to 18 years

• Cumulative incidence of major bleeding at 15 years between groups

  From date of surgery until the date of first documented major bleeding or date of death from any cause, whichever came first, assessed up to 18 years

Study Arms (2)

Bioprosthesis

All patients operated on of isolated AVR with a bioprosthesis implantation between 2000-2015 and age 50-65 years both inclusive.

Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis

Mechanical prosthesis

All patients operated on of isolated AVR with a Mechanical prosthesis implantation between 2000-2015 and age 50-65 years both inclusive.

Procedure: Surgical AVR with bioprosthetic or mechanical prosthesis

Interventions

Surgical AVR with bioprosthetic or mechanical prosthesis PROCEDURE

Surgical AVR with bioprosthetic or mechanical prosthesis

Bioprosthesis; Mechanical prosthesis

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive, with bioprosthesis or mechanical prosthesis implantation

You may qualify if:

• Patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) for severe aortic stenosis from years 2000-2015 both inclusive

You may not qualify if:

• Not reported Residency change (unreachable)
• Need of concomitant surgery
• Reoperations
• Infective endocarditis

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Hospital Universitario Virgen de La Victoria

Málaga, Spain

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

EMILIANO A RODRIGUEZ CAULO, MD, PhD,FECTS

CONTACT

+34951032054; erodriguezcaulo@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: July 23, 2018
• Study Start: July 10, 2018
• Primary Completion: March 31, 2019
• Study Completion: June 30, 2019
• Last Updated: July 23, 2018

Record last verified: 2018-07

Locations

ES (1)