Early Feasibility Study of 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention

NCT07805525 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MCV3830
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Incidence of Device- or Procedure-Related Serious Adverse Events and Complications

  Up to 90 days following implant

• Lead Electrical Performance and Stability Through 12 Months

  From Implant through 12 Months

• Freedom From Device-or Procedure-Related Serious Adverse Events

  Up to 90 days following implant

Other Outcomes (1)

• Tricuspid Valve Parameters

  6 Months Post Implant

Study Arms (1)

Interventional

EXPERIMENTAL

Patients will undergo implant of the Medtronic Model 3830 pacemaker lead via the Middle Cardiac Vein and undergo required electrical testing

Device: Pacemaker

Interventions

Pacemaker DEVICE

Required electrical testing for pacing, sensing, impedance will be completed

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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
• 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)
• Age 18 years or older.
• Signed Patient Informed Consent Form (ICF).
• Life expectancy \< 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care
• Contraindication to transvenous lead implantation, including:

Sponsors & Collaborators

• Minneapolis Heart Institute Foundation: lead
• Cara Medical Ltd: collaborator

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Study Officials

• John S Zakaib, MD

  Minneapolis Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Efrah M Hussein, BS

CONTACT

612-863-0666; Efrah.Hussein@allina.com

Dawn R Witt, PhD

CONTACT

612-385-8299; Dawn.Witt@allina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)