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

Primary Purpose

Tricuspid Regurgitation, Pacemaker Complication

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Additional guidance of lead implantation by transesophageal echocardiography
Sponsored by
LMU Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LMU KlinikumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transesophageal echocardiography + fluoroscopy guided lead implantation

Fluoroscopy guided lead implantation

Arm Description

TEE will be done in addition to fluoroscopy to guide lead implantation.

Fluoroscopy only will be used to guide lead implantation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Death and cardiovascular death
All cause death and cardiovascular death
Heart failure hospitalizations
Unplanned hospitalizations for heart failure
Duration of procedure and radiation
Standard parameters affecting quality of device implantation
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
Sensing, Pacing and RV-stimulation of the right ventricular lead
Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout
Change in functional capacity as assessed NYHA classification
New York Heart Association (NYHA) Functional Classification
Change in quality of life as assessed by MLHFQ
Minnesota Living with Heart Failure Questionnaire

Full Information

First Posted
December 2, 2022
Last Updated
December 19, 2022
Sponsor
LMU Klinikum
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1. Study Identification

Unique Protocol Identification Number
NCT05667519
Brief Title
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Acronym
PLACE
Official Title
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Pacemaker Complication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transesophageal echocardiography + fluoroscopy guided lead implantation
Arm Type
Experimental
Arm Description
TEE will be done in addition to fluoroscopy to guide lead implantation.
Arm Title
Fluoroscopy guided lead implantation
Arm Type
No Intervention
Arm Description
Fluoroscopy only will be used to guide lead implantation.
Intervention Type
Procedure
Intervention Name(s)
Additional guidance of lead implantation by transesophageal echocardiography
Intervention Description
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 Outcome Measure Information:
Title
Worsening of tricuspid regurgitation by at least one grade
Description
Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines
Time Frame
Mean follow up of 2 years
Secondary Outcome Measure Information:
Title
Death and cardiovascular death
Description
All cause death and cardiovascular death
Time Frame
Mean follow up of 2 years
Title
Heart failure hospitalizations
Description
Unplanned hospitalizations for heart failure
Time Frame
Mean follow up of 2 years
Title
Duration of procedure and radiation
Description
Standard parameters affecting quality of device implantation
Time Frame
Mean follow up of 2 years
Title
Right ventricular function and geometry as assessed by transthoracic echocardiography
Description
Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography
Time Frame
Mean follow up of 2 years
Title
Sensing, Pacing and RV-stimulation of the right ventricular lead
Description
Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout
Time Frame
Mean follow up of 2 years
Title
Change in functional capacity as assessed NYHA classification
Description
New York Heart Association (NYHA) Functional Classification
Time Frame
Mean follow up of 2 years
Title
Change in quality of life as assessed by MLHFQ
Description
Minnesota Living with Heart Failure Questionnaire
Time Frame
Mean follow up of 2 years
Other Pre-specified Outcome Measures:
Title
Safety Endpoint
Description
Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision
Time Frame
During hospital stay (up to day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Braun, MD
Phone
+4989440072371
Email
daniel.braun@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Gmeiner, MD
Phone
+4989440072371
Email
jonas.gmeiner@med.uni-muenchen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Braun, MD
Organizational Affiliation
LMU Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
LMU Klinikum
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Braun, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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