BradycardiaSEPTA PMCFNCT07209852
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
An observational study of Bradycardia and Atrioventricular Block, run by Boston Scientific Corporation at 13 sites in 7 countries.
Trial summary
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Atrioventricular Block, Sinus Node Dysfunction
- What is being tested?
- Pacemaker lead
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 19 Dec 2025to 31 Aug 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- 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);
- 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:
- Symptomatic paroxysmal or permanent second- or third-degree AV block,
- Symptomatic bilateral bundle branch block,
- Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block),
- Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias,
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- Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,
- 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:
- Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block,
- VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm,
- Low cardiac output or congestive heart failure secondary to bradycardia;
- 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;
- Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.
Who cannot join
- Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;
- Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);
- Subjects with a Mechanical Tricuspid Valve;
- Subjects requiring hemodialysis or peritoneal dialysis;
- 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;
- Subjects currently on an active organ transplant list;
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- Subject referred to or admitted for hospice care;
- Subjects with a documented life expectancy of less than 12 months;
- Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor);
- Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment;
- 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.
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Italy3 sites
Azienda Ospedaliero-Universitaria di Ferrara-Hospital
Ferrara, Emilia-Romagna, 44100
Azienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, 20162
AOU Maggiore
Novara, 28100
Belgium2 sites
St. Jan-Hospital
Bruges, 8000
Clinique Saint-Pierre Ottignies-Hospital
Brussels, 1340
France2 sites
CHRU de Lille
Lille, 59037
Hospital Europeen Georges-Pompidou (HEGP)
Paris, 75908
Germany2 sites
Saarland University Hospital
Homburg, Saarland, 66421
Marienhospital-Hospital
Osnabrück, Lower Saxony, 49074
Spain2 sites
Virgen de las Nieves University Hospital
Granada, 18014
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
About this study
Official title: Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.
- Being tested
- Pacemaker lead
- Keywords
- Left Bundle Branch Area Pacing (LBBAP), INGEVITY+ Lead, Pacemaker, Cardiac Pacing, Conduction System Pacing, Ventricular Synchrony, Post-Market Clinical Follow-up
- Medical subject headings
- Bradycardia, Atrioventricular Block, Sick Sinus Syndrome, Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker leadDevice
Also called Bradycardia pacemaker system, Left Bundle Branch Area Pacing (LBBAP) Lead
The pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for pacemaker implantation.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving INGEVITY+ lead for left bundle branch area pacing | This group includes adult patients with bradycardia who are indicated for a Boston Scientific pacemaker system. All participants will undergo implantation of an INGEVITY+ pace/sense lead in the left bundle branch area (LBBAP) with a compatible Boston Scientific pacemaker. Receives: Device: Pacemaker lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
LBBA Implant Success Rate
Percentage of subjects in whom the INGEVITY+ lead is successfully implanted in the left bundle branch area (LBBA). Implant success is determined by ECG and procedural criteria, as defined per protocol.
Measured: At the time of implant procedure (Day 0).
Maintenance of Ventricular Synchrony (Paced QRS Duration)
Mean paced QRS duration measured by 12-lead ECG to assess preservation of ventricular synchrony.
Measured: From implant through 3-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start19 Dec 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aurélien Wauters, MD, PhD, Principal investigator, Clinique St-Pierre Ottignies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209852
- Sponsor's protocol ID
- SEPTA PMCF - C2211
- Acronym
- SEPTA PMCF
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)
- ClinicalTrials.gov ID
- NCT07209852
- Acronym / sponsor ID
- SEPTA PMCF / SEPTA PMCF - C2211
- Keywords
- Left Bundle Branch Area Pacing (LBBAP), INGEVITY+ Lead, Pacemaker, Cardiac Pacing, Conduction System Pacing, Ventricular Synchrony, Post-Market Clinical Follow-up
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 7 Oct 2025 (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.
The goal of this observational post-market clinical Follow-up study is to learn about the long-term safety, performance, and clinical benefits of pacing the left bundle branch area (LBBAP) using the INGEVITY+ pacemaker lead in patients with bradycardia who need a pacemaker.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving INGEVITY+ lead for left bundle branch area pacing | – | Device: Pacemaker leadThis group includes adult patients with bradycardia who are indicated for a Boston Scientific pacemaker system. All participants will undergo implantation of an INGEVITY+ pace/sense lead in the left bundle branch area (LBBAP) with a compatible Boston Scientific pacemaker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (14 listed)
- 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);
- 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:
- 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:
- 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;
- Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law.
Key exclusion criteria (11 listed)
- Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication;
- Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA);
- Subjects with a Mechanical Tricuspid Valve;
- Subjects requiring hemodialysis or peritoneal dialysis;
- 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;
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 |
|---|---|---|
| Pacemaker leadAlso: Bradycardia pacemaker system, Left Bundle Branch Area Pacing (LBBAP) LeadThe pacemaker lead under investigation is a bipolar, steroid-releasing pacemaker electrode with active fixation (IS-1 connection) designed for chronic stimulation and sensing in the right atrium, right ventricle or left bundle branch area (LBBA). In this study, the lead is implanted in the LBBA and connected to a single- or dual-chamber pacemaker. Implantation is performed using a compatible, CE-marked catheter for pacemaker implantation. | Device | Patients receiving INGEVITY+ lead for left bundle branch area pacing |
Primary outcome
LBBA Implant Success Rate
Time frame: At the time of implant procedure (Day 0).
Percentage of subjects in whom the INGEVITY+ lead is successfully implanted in the left bundle branch area (LBBA). Implant success is determined by ECG and procedural criteria, as defined per protocol.
Maintenance of Ventricular Synchrony (Paced QRS Duration)
Time frame: From implant through 3-year follow-up.
Mean paced QRS duration measured by 12-lead ECG to assess preservation of ventricular synchrony.
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aurélien Wauters, MD, PhD principal investigator
Clinique St-Pierre Ottignies
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Atrioventricular Block, run by Boston Scientific Corporation at 13 sites in 7 countries.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy, Belgium, France, Germany, Spain and 2 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LBBA Implant Success Rate (time frame: At the time of implant procedure (Day 0).). The study lists 2 primary outcomes in all. 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 27 Oct 2026.