Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Additional guidance of lead implantation by transesophageal echocardiography.
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation, Pacemaker Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. 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. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.
Interventions
- Procedure Additional guidance of lead implantation by transesophageal echocardiography
Transesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position
Primary outcome measures
- Worsening of tricuspid regurgitation by at least one grade [Time frame: Mean follow up of 2 years]
Secondary outcome measures (7)
- Death and cardiovascular death [Time frame: Mean follow up of 2 years]
- Heart failure hospitalizations [Time frame: Mean follow up of 2 years]
- Duration of procedure and radiation [Time frame: Mean follow up of 2 years]
- Right ventricular function and geometry as assessed by transthoracic echocardiography [Time frame: Mean follow up of 2 years]
- Sensing, Pacing and RV-stimulation of the right ventricular lead [Time frame: Mean follow up of 2 years]
- Change in functional capacity as assessed NYHA classification [Time frame: Mean follow up of 2 years]
- Change in quality of life as assessed by MLHFQ [Time frame: Mean follow up of 2 years]
Eligibility criteria
Inclusion criteria
- indication for right ventricular lead implantation according to current guidelines
Exclusion criteria
- preexisting tricuspid regurgitation ≥ grade 2
- other severe heart valve disease
- history of tricuspid valve treatment
- preexisting right ventricular lead
- chronic dialysis
- contraindication for transesophageal echocardiography
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- LMU Klinikum — Munich
Identifiers
NCT: NCT05667519 · PLACE