Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention
Conditions
Brief summary
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.
Interventions
DEVICEPacemaker
Required electrical testing for pacing, sensing, impedance will be completed
Sponsors
Minneapolis Heart Institute Foundation
Cara Medical Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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
Exclusion criteria
are met: 1. Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR 2. Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR 3. Medtronic 3830 CRT-P system implantation 2. Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging. 3. Patient must have prior or planned tricuspid valve intervention, including any of the following: * Surgical tricuspid valve repair (e.g., annuloplasty ring, leaflet repair) OR * Surgical tricuspid valve replacement with a bioprosthetic or mechanical valve OR * Transcatheter tricuspid valve repair (e.g., edge-to-edge repair devices) OR * Transcatheter tricuspid valve replacement (orthotopic or heterotopic) OR * Patients with pre-existing transvalvular RV lead undergoing lead extraction for the management of tricuspid regurgitation who require reimplantation of a new ventricular pacing lead 4. A clinical need to avoid crossing the tricuspid valve, as determined by the treating heart team (e.g., risk of prosthesis-lead interaction, leaflet trauma, or the need to maintain a lead-free tricuspid valve) 5. Age 18 years or older. 6. Signed Patient Informed Consent Form (ICF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | Index Procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Device- or Procedure-Related Serious Adverse Events and Complications | Up to 90 days following implant | 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 | From Implant 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 | Up to 90 days following implant | 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 |
Countries
United States
Contacts
CONTACTEfrah M Hussein, BS
CONTACTDawn R Witt, PhD
PRINCIPAL_INVESTIGATORJohn S Zakaib, MD
Minneapolis Heart Institute
Outcome results
None listed