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Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
RECRUITINGN/ASponsored by LMU Klinikum
Actively Recruiting
PhaseN/A
SponsorLMU Klinikum
Started2022-10-01
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05667519
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions3
Heart DiseasePacemaker ComplicationTricuspid Regurgitation
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Actively Recruiting
PhaseN/A
SponsorLMU Klinikum
Started2022-10-01
Est. completion2027-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05667519