SEPTA PMCF
Research type
Research Study
Full title
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area – Post-Market Clinical Follow-Up (SEPTA PMCF)
IRAS ID
364802
Contact name
Cheuk Fan Chan
Contact email
Sponsor organisation
Boston Scientific
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
This study looks at a new way to help people with slow heart rhythms (bradycardia) who need a pacemaker. Normally, pacemakers send electrical signals to the heart to keep it beating regularly. In this study, doctors will place the pacemaker lead (a thin wire) in a specific area of the heart called the left bundle branch area (LBBA). This area helps control how the heart beats and may offer better results than traditional pacing methods.
The lead used is called INGEVITY+, and it’s already approved for use. The study will follow around 140 adult patients who are getting a pacemaker for the first time. All patients will receive the INGEVITY+ lead in the LBBA, connected to a Boston Scientific pacemaker. The procedure will be done as part of their normal care.
The main goals are to see:
How often the lead can be successfully placed in the LBBA.
Whether this placement helps the heart beat more naturally and keeps the electrical signals in sync.
If the lead works well over time without causing problems.
Patients will be followed for up to 3 years to check how well the device performs and whether they experience any complications. The study does not involve any experimental devices or medicines. It simply observes how well this approved lead works when placed in a newer location within the heart.
By collecting this information, researchers hope to improve pacemaker treatments and help doctors make better decisions for future patients. Participation is voluntary, and patients will continue to receive standard medical care throughout the study.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
25/NW/0377
Date of REC Opinion
23 Feb 2026
REC opinion
Further Information Favourable Opinion