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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
Required electrical testing for pacing, sensing, impedance, and defibrillation will be completed
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
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.
Time frame: Index Procedure
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
Time frame: Up to 90 days following implant
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
Time frame: Up to 90 days following implant
Freedom from Device-or Procedure-Related Serious Adverse Events
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Proportion of participants free from device-or procedure-related serious adverse events through 90 days following implantation.
Time frame: Up to 90 days following implant