Clinical trial NCT05667519: Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Official title: Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Pacemaker Complication
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Worsening of tricuspid regurgitation by at least one grade
timeFrame: Mean follow up of 2 years
Secondary outcomes:
measure: Death and cardiovascular death
timeFrame: Mean follow up of 2 years
measure: Heart failure hospitalizations
timeFrame: Mean follow up of 2 years
measure: Duration of procedure and radiation
timeFrame: Mean follow up of 2 years
measure: Right ventricular function and geometry as assessed by transthoracic echocardiography
timeFrame: Mean follow up of 2 years
measure: Sensing, Pacing and RV-stimulation of the right ventricular lead
timeFrame: Mean follow up of 2 years
measure: Change in functional capacity as assessed NYHA classification
timeFrame: Mean follow up of 2 years
measure: Change in quality of life as assessed by MLHFQ
timeFrame: Mean follow up of 2 years
Other outcomes:
measure: Safety Endpoint
timeFrame: During hospital stay (up to day 7)
Locations:
city: Munich
country: Germany
facility: LMU Klinikum
state: Bavaria
Study officials:
affiliation: LMU Klinikum
name: Daniel Braun, MD
role: PRINCIPAL_INVESTIGATOR
References: