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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Additional guidance of lead implantation by transesophageal echocardiography
Procedure/SurgeryTransesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position
Treatment groups
324 Participants
are divided into 2 treatment groupsGroup A: Transesophageal echocardiography + fluoroscopy guided lead implantationExperimental treatment 1 intervention
Group B: Fluoroscopy guided lead implantationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Worsening of tricuspid regurgitation by at least one grade
Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines
Time frame
Mean follow up of 2 yearsSecondary outcomes
1
Death and cardiovascular death
All cause death and cardiovascular death
Time frame
Mean follow up of 2 years2
Heart failure hospitalizations
Unplanned hospitalizations for heart failure
Time frame
Mean follow up of 2 years3
Duration of procedure and radiation
Standard parameters affecting quality of device implantation
Time frame
Mean follow up of 2 years4
Right ventricular function and geometry as assessed by transthoracic echocardiography
Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography
Time frame
Mean follow up of 2 yearsOther outcomes
1
Safety Endpoint
Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision
Time frame
During hospital stay (up to day 7)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov