Prospective, single center, early feasibility study designed to evaluate the initial safety and device performance of the Medtronic 3930M Lead when implanted via the Middle Cardiac Vein in patients with Tricuspid Valve Regurgitation
Medtronic CRT-D system implant
Medtronic ICD system implant (single or dual chamber)
Anatomical suitability for middle cardiac vein lead placement based on pre procedural imaging.
At least Moderate Tricuspid Valve Regurgitation documented by cardiac imaging
Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care
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 is not manageable with standard therapy.
Single group
Defibrillator
DeviceRequired electrical testing for pacing, sensing, impedance, and defibrillation will be completed
Acute Procedural Success
Acute Procedural Success, defined as successful implantation of the investigational lead with all the following: 1. Successful lead delivery and deployment at the intended MCV location within 4 deployment attempts 2. Stable lead position at completion of the procedure 3. Acceptable electrical performance: * Capture threshold: ≤ 2.0 V at 0.4 ms * Sensing amplitude: ≥ 4.0 mV * Impedance: 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of T-wave Oversensing (TWOS) 6. Absence of P-wave Oversensing (PWOS) 7. Absence of Myopotential Oversensing 8. Successful Defibrillation Test (DFT) with 10J safety margin 9. Absence of any serious adverse events related to the MCV implantation site.
Lead Electrical Performance and Stability through 90 Days
Evaluation of MCV lead electrical performance and stability through 90 days following implantation, including: * Stability of electrical performance (e.g., pacing threshold, sensing, impedance) * Lead stability (e.g., no dislodgement or migration) * Need for lead revision or system modification
Incidence of Device- or Procedure-Related Complications
Number of participants experiencing device- or procedure-related complications through 90 days following implantation: 1\. Incidence of device- or procedure-related major adverse events including, but not limited to: * Death (all-cause or procedure-related) * Cardiac perforation, pericardial effusion, or cardiac tamponade * Clinically significant arrhythmia requiring intervention * Device-related infection requiring intervention * Lead dislodgement requiring intervention * Coronary sinus or venous injury * Clinically significant phrenic nerve stimulation * System revision or extraction
Freedom from Device-or Procedure-Related Serious Adverse Events
Proportion of participants free from device-or procedure-related serious adverse events through 90 days following implantation.
Tricuspid Valve Parameters
Tricuspid Valve Parameters: Tricuspid Valve function, including Tricuspid Valve Regurgitation post implant will be assessed at 6 months post implant or per TTVI protocol
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Minneapolis Heart Institute Foundation
Lead sponsor
Cara Medical Ltd
Collaborator
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