Project Title

Novel technologies in pacing with cardiac implantable electronic devices

Background

Cardiac implantable electronic devices (CIEDs) have been used successfully to treat arrythmias and heart failure for 60 years. Still, a significant proportion of patients fail to achieve sufficient clinical benefit, despite optimal medical treatment and device implantation, so-called non-responders. Additionally, despite major efforts, procedure-related infection remains an important complication in device therapy.

Aim

• Study 1 aims to compare QoL and exercise capacity with leadless AV synchronous VDD pacing using the Micra TPS with conventional transvenous AV synchronous DDD pacing in patients with persistent AV-block.
• Study 2 aims to compare complication rates in patients, with a leadless Micra TPS to conventional pacemakers
• Study 3 aims to compare acute hemodynamic response at different RV lead positioning during CRT-pacing.
• Study 4 aims to compare late clinical outcomes in CRT de novo and upgrade procedures

Methods

• Study 1 is a single center, partly blinded and partly open label, randomized combined parallel and cross-over study with 80 patients randomized 1:1 to receive a standard DDD pacemaker or a leadless VDD pacemaker.
• Study 2 is a retrospective register-based nationwide study with 6,000 patients.
• Study 3 is an acute cross-over study with 12 patients with stable CRT-systems and atrial fibrillation, undergoing LV and RV pressure measurements.
• Study 4 is a retrospective register-based nationwide cohort study with 10,000 patients.