A comparison of traditional pacemaker systems, and the novel leadless pacing therapy in patients who develop heartrhythm disorders as a consequence of transcatheter aortic valve replacement.

INTERVENTION: 1) Interventional arm: implant of LP therapy in TAVI‐patients who are indicated for temporary pacing therapy post‐TAVI implantation. 2) Control arm: standard pacemaker therapy in TAVI‐patients who are indicated for temporary pacing therapy post‐TAVI implantation, and subsequent conventional transvenous permanent pacemaker therapy if applicable. CONDITION: Transcatheter aortic valve replacement, Leadless pacemaker, Conduction disturbance ; ; PRIMARY OUTCOME: Difference in intervention‐related complications SECONDARY OUTCOME: All‐cause mortality ; ; Cardiovascular mortality ; ; Sudden cardiac death (SCD) ; ; Unexpected mortality (composite of sudden cardiac or unknown mortality) ; ; Composite of all‐cause mortality and intervention‐related complications ; ; Major Adverse Cardiac Event ; ; Stroke ischemic or hemorrhagic: classified as disabling or nondisabling ; ; ; ; TIA ; ; Intervention‐related complications individually, defined in 6.4.1 ; ; Functional Improvement from baseline per NYHA functional classification ; ; Left ventricular function (in left ventricular ejection fraction [LVEF]) ; ; Length of in‐hospital stay from randomization to discharge ; ; Time to mobilization ; ; Recurrent hospitalization due to cardiovascular event ; ; Total hospital days from the index procedure to one‐year post procedure ; ; Composite of all‐cause mortality, MACE, recurrent hospitalization for cardiovascular event ; ; Health Related Quality of Life ; ; Cost‐effectiveness ; ; % PPM implantation in TV‐TP group ; ; % Pacing in all pacemaker patients ; ; Patient satisfaction ; ; 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