Can a defibrillator lead thread through the Heart's middle cardiac vein?
NCT ID NCT07811609
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
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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
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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Other studies related to the condition(s) this trial covers.
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