An interventional study of Pacemaker in Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention, 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 2026-09-04.
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 3830 Lead when implanted via the Middle Cardiac Vein in patients with prior or planned tricuspid valve interventions.
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.
Subjects who meet current clinical practice guidelines for implantation of a PPM or CRT-P system and will undergo one of the following procedures are eligible for enrollment, provided all inclusion and no exclusion criteria are met:
Patient must have prior or planned tricuspid valve intervention, including any of the following:
Exclusion Criteria:
to transvenous lead implantation, including:
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.
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.
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 Model 3830 pacemaker lead via the Middle Cardiac Vein and undergo required electrical testing
Device: Pacemaker
Required electrical testing for pacing, sensing, impedance will be completed
Acute Procedural Success
Acute Procedural Success: defined as successful implantation of the SelectSecure™ Model 3830 lead in the targeted proximal septal segment of the middle cardiac vein, absent of any serious adverse events related to the MCV implantation site, and achievement of the following: 1. Successful lead delivery and fixation at the intended MCV location using ≤ 4 deployment attempts 2. Stable lead position at completion of the implant procedure 3. Acceptable acute electrical performance, including: * Capture threshold ≤ 2.0 V at 0.4 ms * Sensing amplitude ≥ 4.0 mV * Lead impedance between 200-1500 Ω 4. No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge 5. Absence of oversensing, including: * T-wave oversensing (TWOS) * P-wave oversensing (PWOS) * Myopotential oversensing * Diaphragm stimulation
Time frame: Index Procedure
Incidence of Device- or Procedure-Related Serious Adverse Events and Complications
Number of participants experiencing device- or procedure-related complications through 90 days following implantation including but not limited to: * Pericardial effusion * Clinically significant perforation * Infection * Coronary sinus or venous injury * Clinically significant phrenic nerve/diaphragmatic stimulation * Lead revision or system extraction due to complications
Time frame: Up to 90 days following implant
Lead Electrical Performance and Stability Through 12 Months
1\. Evaluation of pacing and sensing performance from the MCV lead at implant and during routine follow-up visits (pre-discharge, 3, 6, 9 and 12 months), including: * Stability of capture thresholds * Stability of sensing amplitudes * Lead impedance trends * Percentage pacing * Lead stability (absence of dislodgement or migration) * Need for lead revision or system modification due to performance issues * Presence of conduction system capture at implant * Persistence of conduction system capture at follow up
Time frame: From Implant through 12 Months
Freedom From Device-or Procedure-Related Serious Adverse Events
Short Term Safety will be assessed through 90 days following implantation, including: 1\. Freedom from device- or procedure-related serious adverse events (SAEs) through 90 days
Time frame: Up to 90 days following implant
Tricuspid Valve Parameters
Tricuspid Valve Parameters: Tricuspid valve function, including assessment of Tricuspid Valve Regurgitation will be assessed per TTVI protocol, or at 6 months during this investigation.
Time frame: 6 Months Post Implant
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2028, 14 months later.
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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Minneapolis Heart Institute Foundation