Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLMU Klinikum
About this trial
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
Eligibility criteria
Qualifiers
indication for right ventricular lead implantation according to current guidelines
Disqualifiers
preexisting tricuspid regurgitation ≥ grade 2
other severe heart valve disease
history of tricuspid valve treatment
preexisting right ventricular lead
Trial design
Treatments tested in this trial
- Additional guidance of lead implantation by transesophageal echocardiography
Treatment groups
324 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov