Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalv… (NCT07342036) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion
Germany200 participantsStarted 2024-07-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Worsening of TR of at least 1 grade
Timeframe: over the sutdy period up to 1 year after lead insertion