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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker lead | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From implant through 3-year follow-up. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lead-related Complication-Free Rate | Freedom from lead-related complications (death, serious injury, invasive correction, or permanent loss of device function). | From implant through 3 years. |
Inclusion Criteria:
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,
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.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Goetzke, Dipl.-Ing. (FH) | Contact | 800-227-3422 | septa_pmcf@bsci.com | |
| Gena Kantor, MPH | Contact | 800-227-3422 | septa_pmcf@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Aurélien Wauters, MD, PhD | Clinique St-Pierre Ottignies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jan-Hospital | Recruiting | Bruges | 8000 | Belgium |
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| Clinique Saint-Pierre Ottignies-Hospital | Recruiting | Brussels | 1340 | Belgium |
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| CHRU de Lille | Recruiting | Lille | 59037 | France |
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| Hospital Europeen Georges-Pompidou (HEGP) | Recruiting | Paris | 75908 | France |
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| Marienhospital-Hospital | Recruiting | Osnabrück | Lower Saxony | 49074 | Germany |
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| Saarland University Hospital | Not yet recruiting | Homburg | Saarland | 66421 | Germany |
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| Azienda Ospedaliero-Universitaria di Ferrara-Hospital | Not yet recruiting | Ferrara | Emilia-Romagna | 44100 | Italy |
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| Azienda Ospedaliera Ospedale Niguarda Ca Granda | Not yet recruiting | Milan | 20162 | Italy |
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| AOU Maggiore | Recruiting | Novara | 28100 | Italy |
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| Virgen de las Nieves University Hospital | Recruiting | Granada | 18014 | Spain |
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| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
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| Inselspital Bern | Not yet recruiting | Bern | 3010 | Switzerland |
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| East Surrey Hospital | Recruiting | Redhill | Surrey | RH1 5RH | United Kingdom |
|
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D054537 | Atrioventricular Block |
| D012804 | Sick Sinus Syndrome |
| D002037 | Bundle-Branch Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D001146 | Arrhythmia, Sinus |
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| ID | Term |
|---|---|
| D000098523 | Device Lead Extraction |
| ID | Term |
|---|---|
| D020878 | Device Removal |
| D013514 | Surgical Procedures, Operative |
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