DefibrillatorMCV3930 EFSNCT07811609
Early Feasibility Study of 3930M Defibrillation Lead Implantation Via the Middle Cardiac Vein in Patients With Tricuspid Valve Regurgitation
A study testing Defibrillator in people with Defibrillator and Tricuspid Valve Regurgitation, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Defibrillator, Tricuspid Valve Regurgitation
- What is being tested?
- Defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
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- 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.
- Patient with evidence of active infection or undergoing treatment for an infection.
- Inability to provide informed consent, including:
- Cognitive impairment without a legally authorized representative
- Language or communication barriers that prevent adequate understanding of the study
- 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
- Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- End-Stage Renal Disease (ESRD) on dialysis
- NYHA IV
- Patient participation in another study that precludes concomitant study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Efrah M Hussein, BS, 612-863-0666, efrah.hussein@allina.com
Dawn R Witt, PhD, 612-385-8299, dawn.witt@allina.com
About this study
Official title: 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
- Conditions
- Defibrillator, Tricuspid Valve Regurgitation
- Being tested
- Defibrillator
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefibrillatorDevice
Required electrical testing for pacing, sensing, impedance, and defibrillation will be completed
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Patients will undergo implant of the Medtronic 3930M Defibrillation lead via the Middle Cardiac Vein and undergo required electrical testing Receives: Device: Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Procedural Success
Acute Procedural Success, defined as successful implantation of the investigational lead with all the following:
- Successful lead delivery and deployment at the intended MCV location within 4 deployment attempts
- Stable lead position at completion of the procedure
- Acceptable electrical performance:
- Capture threshold: ≤ 2.0 V at 0.4 ms
- Sensing amplitude: ≥ 4.0 mV
- Impedance: 200-1500 Ω
- No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge
- Absence of T-wave Oversensing (TWOS)
- Absence of P-wave Oversensing (PWOS)
- Absence of Myopotential Oversensing
- Successful Defibrillation Test (DFT) with 10J safety margin
- Absence of any serious adverse events related to the MCV implantation site.
Measured: Index Procedure
Secondary outcomes (3)
Lead Electrical Performance and Stability through 90 Days
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
Measured: Up to 90 days following implant
Incidence of Device- or Procedure-Related Complications
Number of participants experiencing device- or procedure-related complications through 90 days following implantation:
- 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
Measured: Up to 90 days following implant
Freedom from Device-or Procedure-Related Serious Adverse Events
Proportion of participants free from device-or procedure-related serious adverse events through 90 days following implantation.
Measured: Up to 90 days following implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DefibrillatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Cara Medical Ltd
- Responsible party
- Sponsor
- Investigators
- John S Zakaib, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811609
- Sponsor's protocol ID
- MCV 3930
- Acronym
- MCV3930 EFS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes