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

• Sponsor: LMU Klinikum (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05667519
• Collaborator: (none)
• Enrollment: 324
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation; Pacemaker Complication	Procedure: Additional guidance of lead implantation by transesophageal echocardiography	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 324 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
• Actual Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2027
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transesophageal echocardiography + fluoroscopy guided lead implantation TEE will be done in addition to fluoroscopy to guide lead implantation.	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
No Intervention: Fluoroscopy guided lead implantation Fluoroscopy only will be used to guide lead implantation.

Outcome Measures

Primary Outcome Measures

1. 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

Secondary Outcome Measures

1. Death and cardiovascular death [Mean follow up of 2 years]

   All cause death and cardiovascular death

2. Heart failure hospitalizations [Mean follow up of 2 years]

   Unplanned hospitalizations for heart failure

3. Duration of procedure and radiation [Mean follow up of 2 years]

   Standard parameters affecting quality of device implantation

4. Right ventricular function and geometry as assessed by transthoracic echocardiography [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 [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 [Mean follow up of 2 years]

   New York Heart Association (NYHA) Functional Classification

7. Change in quality of life as assessed by MLHFQ [Mean follow up of 2 years]

   Minnesota Living with Heart Failure Questionnaire

Other Outcome Measures

1. Safety Endpoint [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LMU Klinikum	Munich	Bavaria	Germany	81377

Sponsors and Collaborators

• LMU Klinikum

Investigators

• Principal Investigator: Daniel Braun, MD, LMU Klinikum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Braun, MD, Senior attending physician department of cardiology, principal investigator, LMU Klinikum
• ClinicalTrials.gov Identifier: NCT05667519
• Other Study ID Numbers: PLACE
• First Posted: Dec 28, 2022
• Last Update Posted: Dec 28, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Dec 28, 2022