Actively Recruiting
Prevention of Pacemaker Lead Induced Tricuspid Regurgitation by Transesophageal Echo Guided Implantation
Led by LMU Klinikum · Updated on 2022-12-28
324
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method to reduce a common complication called lead-induced tricuspid regurgitation that can happen after pacemaker or ICD lead implantation. This trial compares two techniques for placing the right ventricular lead: one guided by both transesophageal echocardiography and fluoroscopy, and the other guided by fluoroscopy alone. The study aims to see if the additional echocardiography guidance can prevent worsening of tricuspid valve leakage, which is linked to higher rates of death and heart failure hospitalizations. Participants are randomly assigned to one of two groups: one group receives lead implantation guided by both transesophageal echocardiography and fluoroscopy, focusing on placing the lead in a stable position near the tricuspid valve commissure and ventricular apex. The other group undergoes the standard procedure guided by fluoroscopy only. This randomized controlled trial is double-blinded and follows patients for up to 3 years to monitor outcomes. During the study, participants will have echocardiograms assessed by a blinded specialist to measure the severity of tricuspid regurgitation, which is the primary outcome measured over an average of 2 years. Secondary outcomes include death rates, heart failure hospitalizations, procedure duration, radiation exposure, right ventricular function, lead performance, functional capacity, and quality of life. The study involves regular follow-ups with echocardiography and clinical assessments to track these outcomes and safety throughout the trial duration.
CONDITIONS
Brief 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 procedure or use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo pacemaker lead implantation guided either by transesophageal echocardiography plus fluoroscopy or by fluoroscopy alone.
1 implantation visit (in-person)
Duration - Up to 3 years
Participants are followed for up to 3 years to monitor heart function, lead performance, and clinical outcomes.
Regular follow-up visits during this period
Trial Site Locations
Total: 1 location
1
LMU Klinikum
Munich, Bavaria, Germany, 81377
Actively Recruiting
Research Team
D
Daniel Braun, MD
J
Jonas Gmeiner, MD
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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