RecruitingNot ApplicableNCT05667519
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Sponsor
LMU Klinikum
Enrollment
324 participants
Start Date
Oct 1, 2022
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- indication for right ventricular lead implantation according to current guidelines
Exclusion Criteria6
- 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
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Interventions
PROCEDUREAdditional 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
Locations(1)
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NCT05667519
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