Prospective Study of Lead-associated Tricuspid Regurgitat... | NCT07342036

Studies
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion

NCT07342036

Sponsor

Hazem Omran

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Tricuspid Valve Regurgitation
Pacemaker
ICD
Left Bundle Branch Area Pacing

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2024Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Jan 6, 2026

First Submission Date that Met QC Criteria

Jan 6, 2026

First Posted Date

Jan 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The prevalence of tricuspid regurgitation (TR) in patients with a pacemaker or ICD/CRT device varies widely, ranging from 5% to 45% across different study protocols. To date, only retrospective analyses have shown that implantation of a device with a transvalvular lead can cause or worsen TR, highlighting the importance of early diagnosis. The aim of this study is to prospectively evaluate patients indicated for cardiac electronic device implantation to document the incidence of newly developed regurgitation (greater than trace) or worsening of existing regurgitation (by at least one grade). Additionally, the study will investigate predictive factors for the development or progression of TR.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
TR > mild at follow-up	The percentage of patients with at least moderate TR or worse	during study time frame up to 1 year after Pacemaker/ICD implantation
NTproBNP change from baseline	Change in NTproBNP levels from baseline to 6 and 12 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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...)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hazem Omran, MD	Contact	+49 5731 970		homran@hdz-nrw.de
Lena Riemke-Maw, BSc	Contact	+49 5731 97	1258	lriemke-maw@hdz-nrw.de

Overall Officials

Name	Affiliation	Role
Hazem Omran, MD	Herz- und Diabeteszentrum NRW	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herz- und Diabeteszentrum NRW	Recruiting	Bad Oeynhausen	North Rhine-Westphalia	32545	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases