NCT07342036 Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
| NCT ID | NCT07342036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hazem Omran |
| Condition | Tricuspid Valve Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-07-19 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Hazem Omran, MD
PRINCIPAL INVESTIGATOR
Herz- und Diabeteszentrum NRW
Frequently Asked Questions
Who can join the NCT07342036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Valve Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07342036 currently recruiting?
Yes, NCT07342036 is actively recruiting participants. Contact the research team at homran@hdz-nrw.de for enrollment information.
Where is the NCT07342036 trial being conducted?
This trial is being conducted at Bad Oeynhausen, Germany.
Who is sponsoring the NCT07342036 clinical trial?
NCT07342036 is sponsored by Hazem Omran. The principal investigator is Hazem Omran, MD at Herz- und Diabeteszentrum NRW. The trial plans to enroll 200 participants.