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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Required electrical testing for pacing, sensing, impedance will be completed
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Acute Procedural Success
Acute Procedural Success: defined as successful implantation of the SelectSecure™ Model 3830 lead in the targeted proximal septal segment of the middle cardiac vein, absent of any serious adverse events related to the MCV implantation site, and achievement of the following: 1. Successful lead delivery and fixation at the intended MCV location using ≤ 4 deployment attempts 2. Stable lead position at completion of the implant procedure 3. Acceptable acute electrical performance, including: * Capture threshold ≤ 2.0 V at 0.4 ms * Sensing amplitude ≥ 4.0 mV * Lead impedance between 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of oversensing, including: * T-wave oversensing (TWOS) * P-wave oversensing (PWOS) * Myopotential oversensing * Diaphragm stimulation
Time frame: Index Procedure
Incidence of Device- or Procedure-Related Serious Adverse Events and Complications
Number of participants experiencing device- or procedure-related complications through 90 days following implantation including but not limited to: * Pericardial effusion * Clinically significant perforation * Infection * Coronary sinus or venous injury * Clinically significant phrenic nerve/diaphragmatic stimulation * Lead revision or system extraction due to complications
Time frame: Up to 90 days following implant
Lead Electrical Performance and Stability Through 12 Months
1\. Evaluation of pacing and sensing performance from the MCV lead at implant and during routine follow-up visits (pre-discharge, 3, 6, 9 and 12 months), including: * Stability of capture thresholds * Stability of sensing amplitudes * Lead impedance trends * Percentage pacing * Lead stability (absence of dislodgement or migration) * Need for lead revision or system modification due to performance issues * Presence of conduction system capture at implant * Persistence of conduction system capture at follow up
Time frame: From Implant through 12 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Freedom From Device-or Procedure-Related Serious Adverse Events
Short Term Safety will be assessed through 90 days following implantation, including: 1\. Freedom from device- or procedure-related serious adverse events (SAEs) through 90 days
Time frame: Up to 90 days following implant