Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry

NCT04945005 | Completed

• 1 other identifier: 101214
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.

Conditions

Tricuspid Valve Insufficiency; Pacemaker Complication; Echocardiography, Transesophageal

Outcome Measures

Primary Outcomes (1)

• Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

  Lead induced tricuspid regurgitation measured by transthoracic echocardiography

  2 - 7 days post-implant (at hospital discharge)

Secondary Outcomes (4)

• Dose-are product

  Intraprocedural

• Lead revisions

  30 days

• Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

  3 months

• Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)

  12 months

Study Arms (2)

Lead implantation with transesophageal echocardiography

All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance

Procedure: Transesophageal guidance of lead implantation

Lead implantation without transesophageal echocardiography (retrospective)

All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group)

Interventions

Transesophageal guidance of lead implantation PROCEDURE

In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions

Lead implantation with transesophageal echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.

You may qualify if:

• indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines

You may not qualify if:

• pre-existing RV lead
• pre-existing TR \>2

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (1)

LMU Klinikum

Munich, Bavaria, 81377, Germany

Location

Related Publications (1)

• Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.

  PMID: 34887055 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Daniel Braun, PD Dr. med.

  LMU Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 30, 2021
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)