Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve InterventionMCV3830NCT07805525
Early Feasibility Study of 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention
A study testing Pacemaker in people with Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention
- What is being tested?
- Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Medtronic 3830 DDD pacing mode (dual-chamber pacemaker) OR
- Medtronic 3830 VVI pacing mode (single-chamber ventricular pacemaker) OR
- Medtronic 3830 CRT-P system implantation
- Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging.
- Patient must have prior or planned tricuspid valve intervention, including any of the following:
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- 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
- 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)
- Age 18 years or older.
- Signed Patient Informed Consent Form (ICF).
Who cannot join
- Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care
- 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.
- Subject is contraindicated for a single dose of 40.0 µg of beclomethasone dipropionate
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- Patient with evidence of active infection or undergoing treatment for an infection.
- Inability to provide informed consent, including:
- Cognitive impairment without a legally authorized representative
- Language or communication barriers that prevent adequate understanding of the study
- 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
- Pregnant women or breastfeeding women, or women of childbearing potential and who are not on a reliable form of birth regulation method or abstinence
- End-Stage Renal Disease (ESRD) on dialysis
- NYHA IV
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Efrah M Hussein, BS, 612-863-0666, Efrah.Hussein@allina.com
Dawn R Witt, PhD, 612-385-8299, Dawn.Witt@allina.com
About this study
Official title: Early Feasibility Study of Medtronic 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention: MCV 3830 EFS
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.
- Being tested
- Pacemaker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacemakerDevice
Required electrical testing for pacing, sensing, impedance will be completed
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Patients will undergo implant of the Medtronic Model 3830 pacemaker lead via the Middle Cardiac Vein and undergo required electrical testing Receives: Device: Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Successful lead delivery and fixation at the intended MCV location using ≤ 4 deployment attempts
- Stable lead position at completion of the implant procedure
- 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
- No device- or procedure-related Major Adverse Cardiovascular Events (MACE) through hospital discharge
- Absence of oversensing, including:
- T-wave oversensing (TWOS)
- P-wave oversensing (PWOS)
- Myopotential oversensing
- Diaphragm stimulation
Measured: Index Procedure
Secondary outcomes (3)
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
Measured: Up to 90 days following implant
Lead Electrical Performance and Stability Through 12 Months
- 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
Measured: 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:
- Freedom from device- or procedure-related serious adverse events (SAEs) through 90 days
Measured: Up to 90 days following implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Cara Medical Ltd
- Responsible party
- Sponsor
- Investigators
- John S Zakaib, MD, Principal investigator, Minneapolis Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805525
- Sponsor's protocol ID
- MCV3830
- Acronym
- MCV3830
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of Medtronic 3830 Lead Implantation Via the Middle Cardiac Vein in Patients With Prior or Planned Tricuspid Valve Intervention: MCV 3830 EFS
- ClinicalTrials.gov ID
- NCT07805525
- Acronym / sponsor ID
- MCV3830 / MCV3830
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Cara Medical Ltd
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Device: PacemakerPatients will undergo implant of the Medtronic Model 3830 pacemaker lead via the Middle Cardiac Vein and undergo required electrical testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Anatomical suitability for middle cardiac vein lead placement based on pre-procedural CT imaging.
- Patient must have prior or planned tricuspid valve intervention, including any of the following:
- 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)
- Age 18 years or older.
Key exclusion criteria (14 listed)
- Life expectancy < 6 months due to non-cardiac comorbidities or advanced frailty where the procedure is not aligned with goals of care
- Contraindication to transvenous lead implantation, including:
- Subject is contraindicated for a single dose of 40.0 µg of beclomethasone dipropionate
- Patient with evidence of active infection or undergoing treatment for an infection.
- Inability to provide informed consent, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PacemakerRequired electrical testing for pacing, sensing, impedance will be completed | Device | Interventional |
Primary outcome
Acute Procedural Success
Time frame: Index Procedure
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
3 secondary outcomes
Incidence of Device- or Procedure-Related Serious Adverse Events and Complications
Time frame: Up to 90 days following implant
Lead Electrical Performance and Stability Through 12 Months
Time frame: From Implant through 12 Months
Freedom From Device-or Procedure-Related Serious Adverse Events
Time frame: Up to 90 days following implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John S Zakaib, MD principal investigator
Minneapolis Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker in people with Cardiac Conduction Disorders Requiring Permanent Pacing in Patients With Prior or Planned Tricuspid Valve Intervention, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efrah M Hussein, BS (612-863-0666, Efrah.Hussein@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success (time frame: Index Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.