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New pacemaker lead aims to keep Heart's natural rhythm

NCT ID NCT07209852

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 7 times

Summary

This study is testing a pacemaker lead placed in a specific area of the heart called the left bundle branch area. The goal is to see if this placement is safe and helps the heart beat more naturally in people with slow heart rates. About 140 participants will get the lead and be followed over time. The study is observational, meaning researchers will watch what happens without comparing to another treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pacemaker lead (INGEVITY+) implanted in the left bundle branch area
What this could lead to
If successful, this could confirm that pacing the left bundle branch area is a safe and effective way to treat slow heart rhythms while keeping the heart's natural pumping pattern.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove superiority over standard pacing. Risks include lead dislodgement, infection, or ineffective pacing.

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.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects included in SEPTA PMCF will be selected from the physician investigator's general patient population with a brady pacing indication for single or dual-chamber pacemaker implantation where LBBAP is preferred. Diverse racial and gender patient consideration should be implemented when determining potential participants.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

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 intended to undergo initial (de novo) pacing system implant using the INGEVITY+ lead in the left bundle branch area (LBBA) and a Boston Scientific single or dual- chamber pacemaker (Note: no prior attempted pacing system components); 2. Subjects who are indicated for and will receive a Boston Scientific pacemaker system (including the single or dual chamber pacemaker and an INGEVITY+ lead in the LBBA location) for one of the following medical conditions: 1. Symptomatic paroxysmal or permanent second- or third-degree AV block, 2. Symptomatic bilateral bundle branch block, 3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block), 4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, 5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes, 6. Adaptive-rate pacing for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: 7. Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block, 8. VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm, 9. Low cardiac output or congestive heart failure secondary to bradycardia; 3. Subjects willing and capable of providing informed consent and participating in all testing and clinic visits associated with the clinical study at an approved clinical study location and at the intervals defined by protocol; 4. Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication; 2. Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA); 3. Subjects with a Mechanical Tricuspid Valve; 4. Subjects requiring hemodialysis or peritoneal dialysis; 5. Subject has or has had implanted any pacemaker, ICD system, including subcutaneous, transvenous or leadless systems (Note: except for temporary pacing wire at time of enrollment) or CRT system; 6. Subjects currently on an active organ transplant list; 7. Subject referred to or admitted for hospice care; 8. Subjects with a documented life expectancy of less than 12 months; 9. Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor); 10. Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment; 11. Subjects who are unable or unwilling to comply with the follow-up schedule, including those living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome.

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia bundle branch block, familial isolated complete right congestive heart failure progressive familial heart block, type 1A sick sinus syndrome sinoatrial node disorder syncope, familial vasovagal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrioventricular block Bradycardia Bundle-branch block Sinus node dysfunction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

  • AOU Maggiore

    RECRUITING

    Novara, 28100, Italy

  • Azienda Ospedaliera Ospedale Niguarda Ca Granda

    NOT_YET_RECRUITING

    Milan, 20162, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara-Hospital

    RECRUITING

    Ferrara, Emilia-Romagna, 44100, Italy

  • CHRU de Lille

    RECRUITING

    Lille, 59037, France

  • Clinique Saint-Pierre Ottignies-Hospital

    RECRUITING

    Brussels, 1340, Belgium

  • East Surrey Hospital

    RECRUITING

    Redhill, Surrey, RH1 5RH, United Kingdom

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Europeen Georges-Pompidou (HEGP)

    RECRUITING

    Paris, 75908, France

  • Inselspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Marienhospital-Hospital

    RECRUITING

    Osnabrück, Lower Saxony, 49074, Germany

  • Saarland University Hospital

    NOT_YET_RECRUITING

    Homburg, Saarland, 66421, Germany

  • St. Jan-Hospital

    RECRUITING

    Bruges, 8000, Belgium

  • Virgen de las Nieves University Hospital

    RECRUITING

    Granada, 18014, Spain

    Contact Email: •••••@•••••

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