Actively Recruiting
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Led by LMU Klinikum · Updated on 2022-12-28
324
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for right ventricular lead implantation according to current guidelines
You will not qualify if you...
- Preexisting tricuspid regurgitation grade 2 or higher
- Other severe heart valve disease
- History of tricuspid valve treatment
- Preexisting right ventricular lead
- Chronic dialysis
- Contraindication for transesophageal echocardiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LMU Klinikum
Munich, Bavaria, Germany, 81377
Actively Recruiting
Research Team
D
Daniel Braun, MD
CONTACT
J
Jonas Gmeiner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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