Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
PLACE
1 other identifier
interventional
324
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
December 28, 2022
December 1, 2022
5 years
December 2, 2022
December 19, 2022
Conditions
Outcome Measures
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
Mean follow up of 2 years
Secondary Outcomes (7)
Death and cardiovascular death
Mean follow up of 2 years
Heart failure hospitalizations
Mean follow up of 2 years
Duration of procedure and radiation
Mean follow up of 2 years
Right ventricular function and geometry as assessed by transthoracic echocardiography
Mean follow up of 2 years
Sensing, Pacing and RV-stimulation of the right ventricular lead
Mean follow up of 2 years
- +2 more secondary outcomes
Other Outcomes (1)
Safety Endpoint
During hospital stay (up to day 7)
Study Arms (2)
Transesophageal echocardiography + fluoroscopy guided lead implantation
EXPERIMENTALTEE will be done in addition to fluoroscopy to guide lead implantation.
Fluoroscopy guided lead implantation
NO INTERVENTIONFluoroscopy only will be used to guide lead implantation.
Interventions
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
Eligibility Criteria
You may qualify if:
- indication for right ventricular lead implantation according to current guidelines
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LMU Klinikumlead
Study Sites (1)
LMU Klinikum
Munich, Bavaria, 81377, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Braun, MD
LMU Klinikum
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior attending physician department of cardiology, principal investigator
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 28, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
December 28, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share