Patient enrolment

 

The TALENT trial started operations on April 1st 2016 with first Ethics Approval achieved after 6 months at the METC of the Academic Medical Centre Amsterdam. All participating sites were active after 14 months from start of activities.

The TALENT trial included 23 sites in 7 countries. Sites were distributed as follows: The Netherlands (5 sites), UK (6 sites), Spain (4 sites), Poland (3 sites), Hungary (2 sites), Bulgaria (2 sites), Italy (1 site).

The first patient was enrolled on 21st October 2016 at the AMC, Amsterdam, the Netherlands with Prof. de Winter being the site Principal Investigator. Enrolment of all participants, amounting to 1435 was achieved on July 3rd 2017 at Amphia Hospital, Breda, the Netherlands  with Dr. IJsselmuiden being the site Principal Investigator. The achieved average rate of enrolment was 7.3 patients/month/site.

Enrolment per country was distributed as follows: The Netherlands (700 patients), Poland (223 patients), UK (219 patients), Spain (174 patients), Bulgaria (72 patients), Hungary (37 patients), and Italy (10 patients).

The top 3 enrolling sites in the TALENT trial were:

  1. AMC, Amsterdam, the Netherlands, Prof. R. de Winter
  2. Catharina hospital, Eindhoven, the Netherlands, Dr. P. Tonino
  3. Medical Centre Leeuwarden, the Netherlands, Dr. S. Hofma

The TALENT achieved 1 year of follow-up on August 6th 2018 which was used for reporting the primary endpoint. 2-year follow-up was completed on August 19th 2019 and 3-year follow-up was completed on August 26th 2020.