Lead Insertion for Tricuspid Valve Condition
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Recruiting
Observational Study
Tricuspid Valve Regurgitation
Pacemaker
ICD
Left Bundle Branch Area Pacing
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- Hazem Omran · Other
Who this trial is looking for
This trial is looking for patients who need a pacemaker or defibrillator. Participants will undergo heart scans before and after the procedure and attend follow-up visits at 6 and 12 months.
Are You a Good Fit for This Trial?
You may be able to join if
- I need a pacemaker or defibrillator
- I have not been diagnosed with severe tricuspid regurgitation
- I do not have any existing heart devices
- I do not have other severe heart valve disease
- I have not been diagnosed with pre-capillary pulmonary hypertension
- I do not have structural disease of the right ventricle
You may not be able to join if
- I cannot give consent
- I am under 18 years old
- I have relevant pulmonary hypertension
- I have severe tricuspid regurgitation
- I have had lead-explantation
- I have existing valvular heart disease needing treatment
- I have had tricuspid valve surgery
- I have congenital heart disease
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 …
Trial Locations
Loading…
Loading trial locations…
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 …
Contacts