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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pacemaker — DEVICE
  Required electrical testing for pacing, sensing, impedance will be completed

Study Details

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.

Key Dates

First listed

Sep 4, 2026

Start date

Nov 30, 2026

Status verified

Sep 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

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

Primary Outcome Measure

Acute Procedural Success [ Time Frame: Index Procedure ]

Central Contacts

• Efrah M Hussein, BS
  612-863-0666
  [email protected]
• Dawn R Witt, PhD
  612-385-8299
  [email protected]

Locations (1)

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