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Clinical Trials in Germany / NCT05667519
Recruiting Not applicable

Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)

NCT05667519 · tracked via the Priya Life Science Germany tracker
Sponsor
LMU Klinikum
Phase
Not applicable
Started
2022-10-01
Last updated
2022-12-28

Condition(s) studied

Tricuspid RegurgitationPacemaker Complication

Investigational drug(s) / intervention(s)

Additional guidance of lead implantation by transesophageal echocardiography

Additional 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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Worsening of tricuspid regurgitation by at least one grade — Mean follow up of 2 years
    Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines

Trial sites (1)

FacilityCityRegionStatus
LMU Klinikum Munich Bavaria Recruiting

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Other trials for the same condition

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment Recruiting
TARGET 2.0 Study: Safety and Performance of the Cardiovalve TR Replacement System Recruiting
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation Recruiting
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study Active, not recruiting
Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05667519 on ClinicalTrials.gov ↗ ← All trials in Germany