Can a vein in the heart offer a safer route for pacemaker leads?
NCT ID NCT07805525
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This trial tests whether a specific pacemaker lead, the Medtronic 3830, can be safely implanted through the middle cardiac vein in people who have had or plan to have tricuspid valve intervention. The goal is to see if this route provides stable pacing and sensing without causing serious complications. Ten participants will undergo the procedure, and researchers will measure success based on lead placement, electrical performance, and absence of major adverse events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Medtronic 3830 pacemaker lead implanted via the middle cardiac vein
- What this could lead to
- If successful, this approach could offer a safer pacing option for patients who need a pacemaker but have or will have tricuspid valve issues, potentially reducing complications.
- What could go wrong
- This is an early feasibility study with only 10 participants, so results may not apply broadly. Risks include lead dislodgement, perforation, infection, or electrical performance issues.
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 10 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. 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: 1. Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR 2. Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR 3. Medtronic 3830 CRT-P system implantation 2. Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging. 3. Patient must have prior or planned tricuspid valve intervention, including any of the following: * Surgical tricuspid valve repair (e.g., annuloplasty ring, leaflet repair) OR * Surgical tricuspid valve replacement with a bioprosthetic or mechanical valve OR * Transcatheter tricuspid valve repair (e.g., edge-to-edge repair devices) OR * Transcatheter tricuspid valve replacement (orthotopic or heterotopic) OR * Patients with pre-existing transvalvular RV lead undergoing lead extraction for the management of tricuspid regurgitation who require reimplantation of a new ventricular pacing lead 4. A clinical need to avoid crossing the tricuspid valve, as determined by the treating heart team (e.g., risk of prosthesis-lead interaction, leaflet trauma, or the need to maintain a lead-free tricuspid valve) 5. Age 18 years or older. 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 not manageable with standard therapy. 3. Subject is contraindicated for a single dose of 40.0 µg of beclomethasone dipropionate 4. Patient with evidence of active infection or undergoing treatment for an infection. 5. Inability to provide informed consent, including: * Cognitive impairment without a legally authorized representative * Language or communication barriers that prevent adequate understanding of the study 6. 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 7. Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence 8. End-Stage Renal Disease (ESRD) on dialysis 9. NYHA IV
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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