Preventing tricuspid regurgitation during pacemaker lead implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares two methods of guiding pacemaker lead implantation: one using transesophageal echocardiography combined with fluoroscopy, and the other using fluoroscopy alone. Patients will be randomly assigned to one of the two groups and monitored for up to three years to assess the incidence of lead-induced tricuspid regurgitation. The study aims to determine if the echocardiography-guided approach can reduce complications associated with pacemaker implantation. The primary endpoint will be evaluated by a blinded echocardiographer following established guidelines.

Why it matters

Who can join: the full rules

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

Where it's running

• LMU Klinikum
  Munich, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Daniel Braun, MD — LMU Klinikum
• Study coordinator: Daniel Braun, MD
• Email: daniel.braun@med.uni-muenchen.de
• Phone: +4989440072371

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• Compare leadless and left bundle branch pacemakers for heart and valve function

  This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.

  Recruiting Guy's and St Thomas' NHS Foundation Trust · London · NCT07534917

• TriClip for treating tricuspid regurgitation in Japan

  This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.

  Recruiting Abbott Medical Devices · Suita, Osaka · NCT07509658

• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

  This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.

  Recruiting Robert Bosch Medical Center · Stuttgart · NCT07464106

• TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation

  This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.

  Recruiting Cardiovalve Ltd. · Bonn · NCT07334691

• Pivot Extend device to treat severe tricuspid regurgitation

  This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.

  Recruiting Tau-MEDICAL Co., Ltd. · Macquarie Park, New South Wales · NCT07172477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.