Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up

Official title

Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up (SEPTA PMCF)

Overview

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.

Interventions

• Device Pacemaker 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.

Primary outcome measures

• LBBA Implant Success Rate [Time frame: At the time of implant procedure (Day 0).]
• Maintenance of Ventricular Synchrony (Paced QRS Duration) [Time frame: From implant through 3-year follow-up.]

Eligibility criteria

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

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 3 centers

• Azienda Ospedaliero-Universitaria di Ferrara-Hospital — Ferrara
• Azienda Ospedaliera Ospedale Niguarda Ca Granda — Milan
• AOU Maggiore — Novara

Belgium · 2 centers

• St. Jan-Hospital — Bruges
• Clinique Saint-Pierre Ottignies-Hospital — Brussels

France · 2 centers

• CHRU de Lille — Lille
• Hospital Europeen Georges-Pompidou (HEGP) — Paris

Germany · 2 centers

• Marienhospital-Hospital — Osnabrück
• Saarland University Hospital — Homburg

Spain · 2 centers

• Virgen de las Nieves University Hospital — Granada
• Hospital Clinico Universitario Lozano Blesa — Zaragoza

Switzerland · 1 center

• Inselspital Bern — Bern

United Kingdom · 1 center

• East Surrey Hospital — Redhill

Identifiers

NCT: NCT07209852 · SEPTA PMCF - C2211

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗