MCV3830
Early Feasibility Study of 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 10
- Expected completion
- 2028-01
- Funded by
- other
Conditions studied
Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention
What is being tested
- DEVICE: Pacemaker
What it measures
- 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, Index Procedure
Working with
Cara Medical Ltd
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-09-04
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.