Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

Objectives The main objective is to analyze long-term survival (15 years) and major cardiovascular complications (MACE, (early 30-day death, stroke, any prosthesis reoperation, and major bleeding), in patients aged 50-65 years who underwent isolated aortic valve replacement (AVR) due to severe aortic stenosis . Secondary objectives were to analyze the evolution of transprosthetic gradients by echocardiography,, and degree of significant structural degeneration in bioprostheses.

Material and Method: A retrospective analytical study of patients aged 50-65 years who underwent AVR surgery for stenosis between 2000-2015 in 30 centers with a Cardiovascular Surgery Dept. in SPAIN as an inclusion criterion. As exclusion criteria, autonomic change of residence, need for concomitant surgery, previous cardiac interventions and infective endocarditis.

Survival analysis and clinical data records will be performed through the Public Health Care computed medical records , and direct telephone contact with family and / or relatives, in case of doubts. A crude analysis of the data and a posterior analysis by propensity score matching with SPSS or R software will be carried out using a 1: 1 or 2:1 "nearest neighbour" matching protocol based on the Number of total bioprosthesis. A total sample of more than 5000 cases is expected, of which about 1000 would be bioprostheses that would serve as a basis for the pairing. According to previous data(ANDALVALVE STUDY), to find a 4.8% difference in the primary endpoint, two groups of 1025 patients are required for a p = 0.05 and 80% for a bilateral contrast of two independent proportions. Subanalysis will be performed by subgroups of age (50-55 vs. 55-65 years) and another according to the mark of the 2 prostheses of each type most implanted. All statistical analyzes will be two-tailed with an alpha error of 0.05 to consider statistically significant data, and will be reviewed by IBIMA or Private biostatistics. Competing risks analysis will be performed to calculate the cumulative incidence of stroke, reoperation and major bleeding for each prosthesis type.

Conclusions: A positive result (similar survival in group B, with lower complications) could change the current indications of AVR in our environment, allowing the age of indication for bioprostheses in European guidelines to be reduced below 60 years ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03595423
Study type Observational
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact EMILIANO A RODRIGUEZ CAULO, MD, PhD,FECTS
Phone +34951032054
Email erodriguezcaulo@hotmail.com
Status Recruiting
Phase
Start date July 10, 2018
Completion date June 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06066970 - Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery
Recruiting NCT05079672 - Efficacy and Safety of Dexmedetomidine in the Analgesic Prophylaxis , in Patients Undergoing Cardiovascular Surgery Phase 4
Completed NCT03347851 - Post-surgical Aortic Hemodynamics After Aortic Valve Replacement
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Completed NCT04328090 - Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship N/A
Recruiting NCT04359030 - Freestyle-Perimount Calcification Comparison
Completed NCT04958668 - Prospective Evaluation of Volatile Sedation After Heart Valve Surgery N/A
Completed NCT04598360 - Release of Epoxyeicosatrienoic Acids From Erythrocytes During the Use of Extracorporeal Procedures (Heart-lung Machine) N/A
Not yet recruiting NCT04118621 - Role of Chest Ultrasound in Detection of Post-operative Pulmonary Complications After Cardiothoracic Surgery
Recruiting NCT06387446 - Allogeneic Valve Transplantation N/A
Recruiting NCT04843072 - Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis N/A
Completed NCT05804500 - RecoveryPlus Telerehab Platform Pilot Study N/A
Recruiting NCT03885180 - Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy N/A
Completed NCT06154018 - Heparin Reversal With Two Different Protamine Ratios After Cardiopulmonary By-pass. N/A
Recruiting NCT06041308 - Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
Suspended NCT01571791 - Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery Phase 2
Completed NCT06261788 - Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter N/A
Completed NCT06079008 - The Association of Cardiac Valve Calcification and 1-year Mortality After Lower-extremity Amputation in Diabetic Patients
Completed NCT04372654 - Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients N/A
Active, not recruiting NCT03661398 - Caisson Transcatheter Mitral Valve Replacement (TMVR) N/A