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 Type
OBSERVATIONAL
Enrollment
140
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.
St. Jan-Hospital
Bruges, Belgium
RECRUITINGClinique Saint-Pierre Ottignies-Hospital
Brussels, Belgium
RECRUITINGCHRU de Lille
Lille, France
NOT_YET_RECRUITINGHospital Europeen Georges-Pompidou (HEGP)
Paris, France
NOT_YET_RECRUITINGMarienhospital-Hospital
Osnabrück, Lower Saxony, Germany
NOT_YET_RECRUITINGSaarland University Hospital
Homburg, Saarland, Germany
NOT_YET_RECRUITINGAzienda Ospedaliero-Universitaria di Ferrara-Hospital
Ferrara, Emilia-Romagna, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Ospedale Niguarda Ca Granda
Milan, Italy
NOT_YET_RECRUITINGAOU Maggiore
Novara, Italy
NOT_YET_RECRUITINGVirgen de las Nieves University Hospital
Granada, Spain
NOT_YET_RECRUITING...and 3 more locations
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.
Time frame: 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.
Time frame: From implant through 3-year follow-up.
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