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NCT Number: NCT05667519

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

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pacemaker Complication Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LMU Klinikum

Munich, Bavaria, 81377, Germany

Location status: Recruiting

Location contact

Daniel Braun, Prof. Dr.

CONTACT

About this study

Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. 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. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional guidance of lead implantation by transesophageal echocardiography

Procedure

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

Primary outcomes

  1. Worsening of tricuspid regurgitation by at least one grade

    Time frame: Mean follow up of 2 years

    Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines

Secondary outcomes

  1. Death and cardiovascular death

    Time frame: Mean follow up of 2 years

    All cause death and cardiovascular death

  2. Heart failure hospitalizations

    Time frame: Mean follow up of 2 years

    Unplanned hospitalizations for heart failure

  3. Duration of procedure and radiation

    Time frame: Mean follow up of 2 years

    Standard parameters affecting quality of device implantation

  4. Right ventricular function and geometry as assessed by transthoracic echocardiography

    Time frame: Mean follow up of 2 years

    Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography

  5. Sensing, Pacing and RV-stimulation of the right ventricular lead

    Time frame: Mean follow up of 2 years

    Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout

  6. Change in functional capacity as assessed NYHA classification

    Time frame: Mean follow up of 2 years

    New York Heart Association (NYHA) Functional Classification

  7. Change in quality of life as assessed by MLHFQ

    Time frame: Mean follow up of 2 years

    Minnesota Living with Heart Failure Questionnaire

Other outcomes

  1. Safety Endpoint

    Time frame: During hospital stay (up to day 7)

    Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Braun, MD

CONTACT

[email protected]

+4989440072371

Jonas Gmeiner, MD

CONTACT

[email protected]

+4989440072371

Sponsors and collaborators

Lead sponsor

LMU Klinikum

Other

Registry information

Acronym: PLACE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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