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This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transesophageal echocardiography + fluoroscopy guided lead implantation | Experimental | TEE will be done in addition to fluoroscopy to guide lead implantation. |
|
| Fluoroscopy guided lead implantation | No Intervention | Fluoroscopy only will be used to guide lead implantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional guidance of lead implantation by transesophageal echocardiography | Procedure | Transesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening of tricuspid regurgitation by at least one grade | Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines | Mean follow up of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death and cardiovascular death | All cause death and cardiovascular death | Mean follow up of 2 years |
| Heart failure hospitalizations | Unplanned hospitalizations for heart failure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision | During hospital stay (up to day 7) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Braun, MD | Contact | +4989440072371 | daniel.braun@med.uni-muenchen.de | |
| Jonas Gmeiner, MD | Contact | +4989440072371 | jonas.gmeiner@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Braun, MD | LMU Klinikum | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMU Klinikum | Recruiting | Munich | Bavaria | 81377 | Germany |
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|
| Mean follow up of 2 years |
| Duration of procedure and radiation | Standard parameters affecting quality of device implantation | Mean follow up of 2 years |
| Right ventricular function and geometry as assessed by transthoracic echocardiography | Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography | Mean follow up of 2 years |
| Sensing, Pacing and RV-stimulation of the right ventricular lead | Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout | Mean follow up of 2 years |
| Change in functional capacity as assessed NYHA classification | New York Heart Association (NYHA) Functional Classification | Mean follow up of 2 years |
| Change in quality of life as assessed by MLHFQ | Minnesota Living with Heart Failure Questionnaire | Mean follow up of 2 years |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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