abnormal heart rhythm Conduction abnormalities
Conditions
Interventions
Transvenous (temporary) pacing therapy
The patients who are allocated to the interventional arm are implanted with a
leadless pacemaker, preferably within the same procedure as the TAVI, but must
be implanted with a leadless pacemaker wi
Leadless pacing therapy
Transcatheter Aortic Valve Implantation
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patients * 18 years - TAVI patients that have a need for temporary pacing therapy, defined as: 1) intra-procedural or post-procedural (up to 48 hours) high degree AV block 2) intra-procedural or post-procedural (up to 48 hours) (sinus) bradycardia 3) intra-procedural or post-procedural (up to 48 hours) new onset of 1st degree AV block, RBBB, LBBB
Exclusion criteria
Exclusion criteria: -Patients with pre-existing pacing or defibrillation leads -Patients with current ICD implant -Patients with current pacemaker implant -Patients with pacemaker syndrome, has retrograde AV conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing apart from rapid pacing during the TAVI implant procedure* -Patients who are allergic or hypersensitive to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure related complications: Potential device and procedure related risks for both leadless pacemakers include: -Cardiac perforation *Pericardial effusion and cardiac tamponade *Vascular complication -Bleeding *Arteriovenous fistula *Pseudoaneurysm *Failure of vascular closure device requiring intervention -Arrhythmia during device implantation *Asystole *Ventricular tachycardia or ventricular fibrillation -Cardiopulmonary arrest during implantation procedure -Device dislodgement -Device migration during implantation owing to inadequate fixation -Pacing threshold elevation with retrieval and implantation of new device -Other Hemothorax Angina pectoris Pericarditis Acute confusion and expressive aphasia Dysarthria and lethargy after implantation Contrast-induced nephropathy Orthostatic hypotension with weakness Left-leg weakness during implantation Probable pulmonary embolism Ischemic stroke Transvenous Pacing Therapy An overview of potential risks following transvenous pacing therapy is listed below: -Traumatic complications * Perforation of cardiac structure * Pneumo(hemo)thorax * Pericardial effusion -Lead related complications *Lead fractrure *Lead dislocation or disconnection *Insulation problem *Infection (ie, lead endocarditis *Stimulation threshold problem * Diaphragm or pocket stimulation -Pocket complications *Hematoma *Difficult to control bleeding *Infection *Discomfort due to pocket or pacemaker *Skin erosion -Pulse generator problems *Problem with connection screw *Manufacturer recall *Reset to default settings *Device cannot be programmed * Pacemaker tachycardia * Malfunction of software algorithm | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality (All-cause, Cardiovascular, SCD, Unexplained) Device-related complications individually Major Adverse Cardiac Event Stroke ischemic or hemorrhagic: classified as disabling or nondisabling and TIA Functional Improvement from baseline per NYHA functional classification Left ventricular function (in LVEF). Length of in-hospital stay and time to mobilization Recurrent cardiovascular hospitalizations Total hospital days from the index procedure to one-year post procedure Composite of all-cause mortality, MACE, recurrent cardiovascular hospitalization. Health Related Quality of Life Cost effectiveness Percentage PPM implantation in TV-TP group Percentage pacing indication persists, Permanent pacemaker indications Conduction disorder progression in all patients Patient satisfaction | — |
Countries
Netherlands
Outcome results
None listed