Geneva, June 20 -- International Clinical Trials Registry received information related to the study (ACTRN12625000588493) titled 'Clinical study with BIOTRONIK's leadless pacemaker system used for the first time in patients needing ventricular pacing' on June 6.
Study Type: Interventional
Study Design:
Purpose: Treatment
Allocation: Non-randomised trial
Masking: Open (masking not used)
Assignment: Single group
Type of endpoint: Safety
Primary Sponsor: BIOTRONIK Australia Pty. Ltd.
Condition:
Bradycardia
Bradycardia
Cardiovascular - Other cardiovascular diseases
Intervention:
Pre-market, first-in-human, explorative study:
Implantation of a novel leadless pacemaker in patients with class I or II indication for ventricular pacing (...