Patient Enrolment

The GALILEO 4D trial included 12 sites in 5 countries, and were distributed as follows: Denmark (3 sites), Germany (3 sites), Switzerland (2 sites), The Netherlands (1 sites), and the U.S.A. (3 sites).

The first patient was enrolled on May 23rd 2016 at Copenhagen University Hospital Rigshospitalet, Denmark with Dr. Lars Søndergaard being the site Principal Investigator. Enrolment of all participants, amounting to 231 was achieved exactly two years later at the same clinical site. The achieved rate of enrolment was 0.80 patients/site/month.

Enrolment per country was distributed as follows: Denmark (148 patients), U.S.A. (37 patients), Germany (28 patients), Switzerland (14 patients), The Netherlands (4 patients). The top 3 enrolling sites in the GALILEO 4D  were:

  1. Copenhagen University Hospital Rigshospitalet, Denmark, Dr. Lars Søndergaard (89 patients)
  2. Aarhus University Hospital, Denmark, Dr. Christian Terkelsen (45 patients)
  3. Cedars Sinai Medical Center, U.S.A., Dr. Raj Makkar (17 patients) & Mount Sinai Hospital, U.S.A., Dr. Annapoorna Kini (17 patients)

The GALILEO 4D achieved 90 days of follow-up on July 3rd 2018, which was used for reporting the primary endpoint.