Minneapolis Heart Institute Foundation
Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3830 Lead when implanted via the Middle Cardiac Vein in patients with prior or planned tricuspid valve interventions.
Inclusion Criteria: 1. Subjects who meet current clinical practice guidelines for implantation of a PPM or CRT-P system and will undergo one of the following procedures are eligible for enrollment, provided all inclusion and no exclusion criteria are met: 1. Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR 2. Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR 3. Medtronic 3830 CRT-P system implantation 2. Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging. 3. Patient must have prior or planned tricuspid va…
Required electrical testing for pacing, sensing, impedance will be completed
Arctuva estimate
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