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

You may not be if

• 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).
• 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