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Can a defibrillator lead thread through the Heart's middle cardiac vein?

NCT ID NCT07811609

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing a new defibrillator lead called the Medtronic OmniaSecure Model 3930M in people who need a defibrillator and also have moderate or worse tricuspid valve regurgitation. The lead is placed through the middle cardiac vein, a different route than usual, with the goal of avoiding worsening the leaky valve. The study will check whether the lead can be implanted successfully, whether it delivers reliable electrical signals, and whether it stays in place for at least 90 days. Only five participants will take part in this early feasibility study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medtronic OmniaSecure Model 3930M defibrillation lead
What this could lead to
If it works, this could offer a new way to place a defibrillator lead in people with tricuspid valve regurgitation, possibly avoiding damage to the tricuspid valve.
What could go wrong
This is a very small, early feasibility study with only five participants, so safety and performance are still uncertain. The lead may not work as intended, could move out of place, or cause complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 5 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.