Pacemaker Complication, Tricuspid Regurgitation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAdditional guidance of lead implantation by transesophageal echocardiography
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
Sponsors
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* indication for right ventricular lead implantation according to current guidelines
Exclusion criteria
* preexisting tricuspid regurgitation ≥ grade 2 * other severe heart valve disease * history of tricuspid valve treatment * preexisting right ventricular lead * chronic dialysis * contraindication for transesophageal echocardiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worsening of tricuspid regurgitation by at least one grade | Mean follow up of 2 years | Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death and cardiovascular death | Mean follow up of 2 years | All cause death and cardiovascular death |
| Heart failure hospitalizations | Mean follow up of 2 years | Unplanned hospitalizations for heart failure |
| Duration of procedure and radiation | Mean follow up of 2 years | Standard parameters affecting quality of device implantation |
| Sensing, Pacing and RV-stimulation of the right ventricular lead | Mean follow up of 2 years | Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout |
| Change in functional capacity as assessed NYHA classification | Mean follow up of 2 years | New York Heart Association (NYHA) Functional Classification |
| Change in quality of life as assessed by MLHFQ | Mean follow up of 2 years | Minnesota Living with Heart Failure Questionnaire |
| Right ventricular function and geometry as assessed by transthoracic echocardiography | Mean follow up of 2 years | Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | During hospital stay (up to day 7) | Freedom from esophageal injury, pericardial effusion and pneumothorax requiring intervention as well as lead infection/-displacement requiring lead revision |
Countries
Germany
Contacts
Primary ContactDaniel Braun, MD
Backup ContactJonas Gmeiner, MD
Outcome results
None listed