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

NCT ID: NCT05667519

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2027-10-31

Brief Summary

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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

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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.

Conditions

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Tricuspid Regurgitation Pacemaker Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transesophageal echocardiography + fluoroscopy guided lead implantation

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

Group Type EXPERIMENTAL

Additional guidance of lead implantation by transesophageal echocardiography

Intervention Type 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

Fluoroscopy guided lead implantation

Fluoroscopy only will be used to guide lead implantation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

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Daniel Braun, MD

Senior attending physician department of cardiology, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Braun, MD

Role: PRINCIPAL_INVESTIGATOR

LMU Klinikum

Locations

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LMU Klinikum

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniel Braun, MD

Role: CONTACT

Phone: +4989440072371

Email: [email protected]

Jonas Gmeiner, MD

Role: CONTACT

Phone: +4989440072371

Email: [email protected]

Facility Contacts

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Daniel Braun, Prof. Dr.

Role: primary

Other Identifiers

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PLACE

Identifier Type: -

Identifier Source: org_study_id