An interventional study of Defibrillator in Defibrillator and Tricuspid Valve Regurgitation, sponsored by Minneapolis Heart Institute Foundation. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Minneapolis Heart Institute Foundation · Not applicable, Interventional, and Device feasibility
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
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 5 is below the median of 60 across 128 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Minneapolis Heart Institute Foundation is the lead sponsor of 34 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject meets current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
Subject meets both of the following:
Exclusion Criteria:
to transvenous lead implantation, including:
Patients with a medical condition that precludes them from undergoing defibrillation testing:
Inability to provide , including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Index Procedure
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
Time frame: 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: 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
Time frame: 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.
Time frame: Up to 90 days following implant
Tricuspid Valve Parameters
Tricuspid Valve Parameters: Tricuspid Valve function, including Tricuspid Valve Regurgitation post implant will be assessed at 6 months post implant or per TTVI protocol
Time frame: 6 Month Post Implant
Start is estimated for Nov 2026; primary completion for Jan 2028, 14 months later.
Of 85 interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 58. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tricuspid Valve Insufficiency →
Minneapolis Heart Institute Foundation