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.
Subjects who meet current clinical practice guidelines for implantation of a PPM or CRT-P system and will undergo one of the following procedures are eligible for enrollment, provided all inclusion and no
Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR
Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR
Medtronic 3830 CRT-P system implantation
Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging.
Single group
Pacemaker
DeviceRequired electrical testing for pacing, sensing, impedance will be completed
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
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
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
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
Tricuspid Valve Parameters
Tricuspid Valve Parameters: Tricuspid valve function, including assessment of Tricuspid Valve Regurgitation will be assessed per TTVI protocol, or at 6 months during this investigation.
Click on the lead sponsor to view all of their trials.
Minneapolis Heart Institute Foundation
Lead sponsor
Cara Medical Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
