Tricuspid Valve RegurgitationLITRNCT07342036
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
An observational study of Tricuspid Valve Regurgitation and Pacemaker, run by Hazem Omran at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation, Pacemaker, ICD
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2024to 30 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication
Who may be able to join
- 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...)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Hazem Omran, MD, +49 5731 972, homran@hdz-nrw.de
Lena Riemke-Maw, BSc, +49 5731 970, lriemke-maw@hdz-nrw.de
About this study
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.
Read the 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.
- Keywords
- tricuspid regurgitation, lead-related TR, lead-associated TR
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over the sutdy period up to 1 year after lead insertion
Secondary outcomes (3)
TR > mild at follow-up
The percentage of patients with at least moderate TR or worse
Measured: 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
Measured: at 6 and at 12 months after Pacemaker/ICD implantation
Hospitalization for heart failure (HFH)
Any uplanned hopsitalization with requirement of iv diuretics therapy after inclusion
Measured: up to 12 months after Pacemaker/ICD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start19 Jul 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hazem Omran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hazem Omran, Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
- Investigators
- Hazem Omran, MD, Principal investigator, Herz- und Diabeteszentrum NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342036
- Sponsor's protocol ID
- HDZ-KA_024_HO
- Acronym
- LITR
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
- ClinicalTrials.gov ID
- NCT07342036
- Acronym / sponsor ID
- LITR / HDZ-KA_024_HO
- Keywords
- tricuspid regurgitation, lead-related TR, lead-associated TR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hazem OmranUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have been indicated to have a new cardiac device with a transvalvular probe implanted for any given indication
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Worsening of TR of at least 1 grade
Time frame: over the sutdy period up to 1 year after lead insertion
Worsening of tricuspid regurgitation of at least one grade from baseline before lead insertion through tricuspid valve
3 secondary outcomes
TR > mild at follow-up
Time frame: during study time frame up to 1 year after Pacemaker/ICD implantation
NTproBNP change from baseline
Time frame: at 6 and at 12 months after Pacemaker/ICD implantation
Hospitalization for heart failure (HFH)
Time frame: up to 12 months after Pacemaker/ICD implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hazem Omran, MD principal investigator
Herz- und Diabeteszentrum NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Valve Regurgitation and Pacemaker, run by Hazem Omran at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hazem Omran, MD (+49 5731 970, homran@hdz-nrw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of TR of at least 1 grade (time frame: over the sutdy period up to 1 year after lead insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.