NCT07342036

Brief Summary

The goal of this clinical trial is to record the incidence of newly developed or worsening tricuspid valve regurgitation (TR) following the implantation of a pacemaker or defibrillator with a transvenous lead. To collect this data, a transthoracic echocardiogram (TTE) with 3D imaging of the tricuspid valve (TV) will be performed before and after pacemaker implantation, with particular emphasis on assessing the tricuspid valve. Additionally, routine follow-up visits will be conducted at 6 and 12 months post-intervention, during which a TTE, ECG, NT-proBNP measurement, and pacemaker check will be performed.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jul 2024Jan 2027

Study Start

First participant enrolled

July 19, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

PacemakerICDLeft Bundle Branch Area PacingTricuspid Valve Regurgitation

Keywords

tricuspid regurgitationlead-related TRlead-associated TR

Outcome Measures

Primary Outcomes (1)

  • Worsening of TR of at least 1 grade

    Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve

    over the sutdy period up to 1 year after lead insertion

Secondary Outcomes (3)

  • TR > mild at follow-up

    during study time frame up to 1 year after Pacemaker/ICD implantation

  • NTproBNP change from baseline

    at 6 and at 12 months after Pacemaker/ICD implantation

  • Hospitalization for heart failure (HFH)

    up to 12 months after Pacemaker/ICD implantation

Study Arms (3)

Pacemaker-standard

Only pacemaker with standard positioning (no ICD leads, no LBBaP)

ICD

any ICD leads through tricuspid valve

LBBaP

Left bundle branch area pacing leads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication

You may qualify if:

  • medically indicated for pacemaker, ICD- or CRT implantation
  • No previous diagnosis of severe tricuspid regurgitation on enrollment
  • No existing transvalvular device (must be first implantation)
  • No other diagnosed severe valvular heart disease
  • Not previous diagnosis with pre-capillary pulmonary hypertension
  • No previous diagnosis of structural disease of the right ventricle (i.e. ACM, cardiac sarcoidosis, carcinoid...)

You may not qualify if:

  • Patients unable to give consent
  • Under the age of 18 years
  • Relevant pre-capillary pulmonary hypertension according to decision of the heart-team (sPAP echo \>70 mmHg)
  • Severe tricuspid valve regurgitation (Grade 3 or worse) on enrollment
  • Patients who have undergone Lead-explantation
  • Exisiting valvular heart disease requiring treatment according to the decision of the heart-team. These patients may be enrolled in the study following treatment.
  • Previous tricuspid valve surgery
  • Patients with congenital heart disease (i.e. tetralogy of fallot, Ebstein's anomaly,...)
  • Pregnant or breastfeeding women
  • Life expectancy \< 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Hazem Omran, MD

    Herz- und Diabeteszentrum NRW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hazem Omran, MD

CONTACT

+49 5731 970homran@hdz-nrw.de

Lena Riemke-Maw, BSc

CONTACT

+49 5731 97lriemke-maw@hdz-nrw.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

July 19, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)