• Skip to primary navigation
  • Skip to main content
  • Skip to footer
AKRN

AKRN

Scientific Consulting

  • Services
    • Clinical Services
    • Regulatory Services
    • Medical Writing
  • Team
  • News
  • COVID-19 Clinical Trials
  • Contact
  • Job Offers

Heart Transplantation Clinical Trials in Spain

January 14, 2021 by Ariadna Navarro

Heart transplantation: aetiology and history

Heart transplantation is the surgical replacement of a diseased, failing heart with a compatible and healthier heart from a donor. Patients with advanced heart failure undergo heart transplantation only when other treatment options have not succeeded. Heart failure can occur due to several conditions, including cardiomyopathy, coronary artery disease, heart valve disease, congenital heart disease, ventricular arrhythmias, etc.

Dr Christiaan Nethling Barnard, a South African doctor in Cape Town, conducted the first clinical interhuman heart transplant in 1967. The survival time for the first heart transplanted patients ranged from a few hours to a few months. Currently, heart transplantation is a widely accepted treatment for advanced heart failure, with a 1-year survival of 91% and a median survival of 12 to 13 years. The average number of heart transplantations since the 90s has plateaued at about 3500 transplantations per year. This number is not expected to increase, mostly due to the limitation in donor supply.

Heart transplant in Spain: legislation and numbers

Spain has been the worldwide leader in donations and transplants for 28 consecutive years. In 2019, Spain provided 20% of donors in Europe and 6% of donors worldwide, with a rate of 49.6 donors per population million. There were 2301 donors and 5449 successful transplants. Of these, 300 were heart transplantations.

The high numbers above are mostly explained by the “opt-out” system contemplated in the national organ extraction and transplantation law dating from 1979. This law considers that all deceased people as donors (even if they have never registered officially) unless there is an express opposition from the deceased or the direct family. Last year, 86% of potential donor families agreed to the donation. Economically, donations in Spain are always altruist and are 100% covered by the national health system. Moreover, the national transplant organization (ONT) coordinates the transplants nationally, communicating with all the hospitals that can perform extractions and transplant surgeries, and keeping a national database.

Heart transplant unmet medical needs and clinical trials

Despite the advancements of heart transplantation technology and the improvement in survival rates, clinical trials are still needed to assess new heart preservation technologies and surgical techniques. As of 8th of December 2020, ClinicalTrials.gov, the largest clinical trial database, lists 358 studies with the clinical condition “heart transplantation” of which 64 are currently recruiting. Surprisingly, despite being an organ transplant world leader, Spain is only involved in 16 out of the 358 heart transplantation studies (less than 5%), and 5 out of the 64 currently recruiting (7.8%). This finding suggests that there is an unlocked potential for a successful and quickly recruiting heart transplant (and organ transplant in general) clinical trials in Spain.

The team at AKRN are experts in ISO 14155 and good clinical practices (GCP), we have an excellent knowledge of competent authority and ethics committee submissions in Spain and a network of professional contacts in the country leader hospitals. AKRN can help you set up and execute your heart or organ transplant clinical trial in Spain, from site selection and site initiation and maintenance phase to close-out.

Share this article

Category iconClinical Trial,  ISO 14155,  Medical Technology Tag iconhistory,  legislation,  transplantation

Request a free consultation

Our team will help you to find the best solution for your needs. Our medical device experience and clinical knowledge can help you plan, set up, and execute a clinical trial, or performance study, in an optimal way.

Footer

AKRN Spain

AKRN Scientific Consulting S.L.
Address: Calle Cristo de los Remedios 2
Postal Code: ES-28703 Madrid
Phone: +34 6 9777 13 47
VAT ID: ES-B87990925

AKRN Sweden

AKRN Scientific Consulting A.B.
Address: Tytterövägen 26
Postal Code: SE-82595 Hudiksvall
Phone: +46 8 4373 74 93
VAT ID:

Contact details

info@akrnconsulting.com
Go to contact

Content

  • Medical Device Consulting Services
  • Clinical Studies for Medical Devices
  • Medical Writing
  • MedTech Regulatory Services
  • Contact

Resources

  • Articles
  • Resources
  • Job Offers

Latest articles

  • 2020 Results: Exceptional Growth February 24, 2021
  • Conducting clinical investigations successfully February 21, 2021
  • CER according to the MDR February 3, 2021
  • Heart Transplantation Clinical Trials in Spain January 14, 2021
  • IVD Clinical Performance Studies January 8, 2021
  • What is the IVDR? December 21, 2020

AKRN Scientific Consulting S.L ha sido beneficiaria del Fondo Europeo de Desarrollo Regional cuyo objetivo es mejorar la competitividad de las Pymes y gracias al cual ha puesto en marcha un Plan de Marketing Digital Internacional con el objetivo de mejorar su posicionamiento online en mercados exteriores durante el año 2020. Para ello ha contado con el apoyo del Programa XPANDE DIGITAL de la Cámara de Comercio de Burgos.
“Una manera de hacer Europa”

  • Facebook
  • Instagram
  • LinkedIn
  • Twitter

Privacy policy – Cookie Policy – Legal Notice –  Copyright © 2021. All rights reserved. Return to top

We are using cookies to give you the best experience on our website.

You can find out more about which cookies we are using or switch them off in settings.

Privacy Overview
AKRN

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

3rd Party Cookies

This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages.

Keeping this cookie enabled helps us to improve our website.

Please enable Strictly Necessary Cookies first so that we can save your preferences!

Cookie Policy

More information about our Cookie Policy