Early Feasibility Study of 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation

NCT07811609 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MCV 3930
• Study Type: interventional
• Target: 5
• 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 3930M Lead when implanted via the Middle Cardiac Vein in patients with Tricuspid Valve Regurgitation

Conditions

Defibrillator; Tricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• Acute Procedural Success

  Acute Procedural Success, defined as successful implantation of the investigational lead with all the following: 1. Successful lead delivery and deployment at the intended MCV location within 4 deployment attempts 2. Stable lead position at completion of the procedure 3. Acceptable electrical performance: * Capture threshold: ≤ 2.0 V at 0.4 ms * Sensing amplitude: ≥ 4.0 mV * Impedance: 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of T-wave Oversensing (TWOS) 6. Absence of P-wave Oversensing (PWOS) 7. Absence of Myopotential Oversensing 8. Successful Defibrillation Test (DFT) with 10J safety margin 9. Absence of any serious adverse events related to the MCV implantation site.

  Index Procedure

Secondary Outcomes (3)

• Lead Electrical Performance and Stability through 90 Days

  Up to 90 days following implant

• Incidence of Device- or Procedure-Related Complications

  Up to 90 days following implant

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

  Up to 90 days following implant

Other Outcomes (1)

• Tricuspid Valve Parameters

  6 Month Post Implant

Study Arms (1)

Interventional

EXPERIMENTAL

Patients will undergo implant of the Medtronic 3930M Defibrillation lead via the Middle Cardiac Vein and undergo required electrical testing

Device: Defibrillator

Interventions

Defibrillator DEVICE

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

Interventional

Eligibility Criteria

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

You may qualify if:

• Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
• Medtronic CRT-D system implant
• Medtronic ICD system implant (single or dual chamber)
• Anatomical suitability for middle cardiac vein lead placement based on pre procedural imaging.
• Subject meets both of the following:
• At least Moderate Tricuspid Valve Regurgitation documented by cardiac imaging
• A clinical goal to avoid worsening tricuspid valve regurgitation as determined by the treating physician and/or the patient
• Age 18 years or older.
• Subject is willing to undergo implant defibrillation testing
• Signed Patient Informed Consent Form (ICF).

You may not qualify if:

• 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:
• Severe or occlusive disease of the axillary/subclavian venous system
• Coronary sinus or middle cardiac vein occlusion, severe stenosis, or anatomy prohibiting safe lead delivery
• Known hypercoagulable state or bleeding disorder is not manageable with standard therapy.
• Subject is contraindicated for ≤1 mg dexamethasone acetate
• Patients with a medical condition that precludes them from undergoing defibrillation testing:
• Pre-existing or suspected pneumothorax
• Severe aortic stenosis
• Current Intracardiac LA or LV thrombus
• Severe proximal three-vessel or left main coronary artery disease without revascularization
• Hemodynamic instability
• Unstable angina
• Recent stroke or transient ischemic attack (within the last 6 months)
• Known inadequate external defibrillation

Sponsors & Collaborators

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

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• John S Zakaib, MD

  Minneapolis Heart Institute Foundation

  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 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

US (1)