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

Tricuspid Regurgitation Clinical Trial

— PLACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667519
• Other study ID #: PLACE
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 2027

Study information

• Verified date: December 2022
• Source: LMU Klinikum
• Contact: Daniel Braun, MD
• Phone: +4989440072371
• Email: daniel.braun[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker Complication
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint	Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision	During hospital stay (up to day 7)
Primary	Worsening of tricuspid regurgitation by at least one grade	Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines	Mean follow up of 2 years
Secondary	Death and cardiovascular death	All cause death and cardiovascular death	Mean follow up of 2 years
Secondary	Heart failure hospitalizations	Unplanned hospitalizations for heart failure	Mean follow up of 2 years
Secondary	Duration of procedure and radiation	Standard parameters affecting quality of device implantation	Mean follow up of 2 years
Secondary	Right ventricular function and geometry as assessed by transthoracic echocardiography	Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography	Mean follow up of 2 years
Secondary	Sensing, Pacing and RV-stimulation of the right ventricular lead	Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout	Mean follow up of 2 years
Secondary	Change in functional capacity as assessed NYHA classification	New York Heart Association (NYHA) Functional Classification	Mean follow up of 2 years
Secondary	Change in quality of life as assessed by MLHFQ	Minnesota Living with Heart Failure Questionnaire	Mean follow up of 2 years