Early Feasibility Study of 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention

Early Feasibility Study of Medtronic 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention: MCV 3830 EFS

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 valve intervention, including any of the following:

   • Surgical tricuspid valve repair (e.g., annuloplasty ring, leaflet repair) OR
   • Surgical tricuspid valve replacement with a bioprosthetic or mechanical valve OR
   • Transcatheter tricuspid valve repair (e.g., edge-to-edge repair devices) OR
   • Transcatheter tricuspid valve replacement (orthotopic or heterotopic) OR
   • Patients with pre-existing transvalvular RV lead undergoing lead extraction for the management of tricuspid regurgitation who require reimplantation of a new ventricular pacing lead

4. A clinical need to avoid crossing the tricuspid valve, as determined by the treating heart team (e.g., risk of prosthesis-lead interaction, leaflet trauma, or the need to maintain a lead-free tricuspid valve)

5. Age 18 years or older.

6. Signed Patient Informed Consent Form (ICF).

Exclusion Criteria:

1. Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care

2. Contraindication to transvenous lead implantation, including:

   • Severe or occlusive disease of the axillary/subclavian venous system
   • Coronary sinus or middle cardiac vein occlusion, severe stenosis, or anatomy prohibiting safe lead delivery
   • Known hypercoagulable state or bleeding disorder not manageable with standard therapy.

3. Subject is contraindicated for a single dose of 40.0 µg of beclomethasone dipropionate

4. Patient with evidence of active infection or undergoing treatment for an infection.

5. Inability to provide informed consent, including:

   • Cognitive impairment without a legally authorized representative
   • Language or communication barriers that prevent adequate understanding of the study

6. Unable to follow through study protocol for any reasons (social support, distance from research center, insurance denial, mental illness etc.) in the investigator's judgement

7. Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence

8. End-Stage Renal Disease (ESRD) on dialysis

9. NYHA IV