Early Feasibility Study of 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation (MCV3930 EFS)

September 3, 2026 updated by: Minneapolis Heart Institute Foundation

Early Feasibility Study of Medtronic OmniaSecure Model 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation: MCV3930 EFS

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Contact:
        • Principal Investigator:
          • John S Zakaib, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)
  2. Anatomical suitability for middle cardiac vein lead placement based on pre procedural imaging.

  3. 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
  4. Age 18 years or older.
  5. Subject is willing to undergo implant defibrillation testing
  6. Signed Patient Informed Consent Form (ICF).

Exclusion Criteria:

  1. Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care

  2. 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.
  3. Subject is contraindicated for ≤1 mg dexamethasone acetate

  4. 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
    • LVEDD >70 mm
    • Any other known medical condition not listed that precludes their participation in the opinion of the Investigator.
  5. Patient with evidence of active infection or undergoing treatment for an infection.

  6. Inability to provide informed consent, including:

    • Cognitive impairment without a legally authorized representative
    • Language or communication barriers that prevent adequate understanding of the study
  7. Unable to follow through study protocol for any reasons (social support, distance from research center, insurance denial, mental illness etc.) in the investigator's judgement
  8. Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
  9. End-Stage Renal Disease (ESRD) on dialysis
  10. NYHA IV
  11. Patient participation in another study that precludes concomitant study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional
Patients will undergo implant of the Medtronic 3930M Defibrillation lead via the Middle Cardiac Vein and undergo required electrical testing
Device: Defibrillator
Required electrical testing for pacing, sensing, impedance, and defibrillation will be completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Procedural Success
Time Frame: Index Procedure

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lead Electrical Performance and Stability through 90 Days
Time Frame: Up to 90 days following implant

Evaluation of MCV lead electrical performance and stability through 90 days following implantation, including:

  • Stability of electrical performance (e.g., pacing threshold, sensing, impedance)
  • Lead stability (e.g., no dislodgement or migration)
  • Need for lead revision or system modification
Up to 90 days following implant
Incidence of Device- or Procedure-Related Complications
Time Frame: Up to 90 days following implant

Number of participants experiencing device- or procedure-related complications through 90 days following implantation:

1. Incidence of device- or procedure-related major adverse events including, but not limited to:

  • Death (all-cause or procedure-related)
  • Cardiac perforation, pericardial effusion, or cardiac tamponade
  • Clinically significant arrhythmia requiring intervention
  • Device-related infection requiring intervention
  • Lead dislodgement requiring intervention
  • Coronary sinus or venous injury
  • Clinically significant phrenic nerve stimulation
  • System revision or extraction
Up to 90 days following implant
Freedom from Device-or Procedure-Related Serious Adverse Events
Time Frame: Up to 90 days following implant
Proportion of participants free from device-or procedure-related serious adverse events through 90 days following implantation.
Up to 90 days following implant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tricuspid Valve Parameters
Time Frame: 6 Month Post Implant
Tricuspid Valve Parameters: Tricuspid Valve function, including Tricuspid Valve Regurgitation post implant will be assessed at 6 months post implant or per TTVI protocol
6 Month Post Implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Cara Medical Ltd

Investigators

  • Principal Investigator: John S Zakaib, MD, Minneapolis Heart Institute Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

September 3, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCV 3930

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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