NCT07209852 Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
| NCT ID | NCT07209852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Scientific Corporation |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2025-12-19 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. 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); 2. 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: 1. Symptomatic paroxysmal or permanent second- or third-degree AV block, 2. Symptomatic bilateral bundle branch block, 3. Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block), 4. Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias, 5. Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes, 6. 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: 7. Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block, 8. VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm, 9. Low cardiac output or congestive heart failure secondary to bradycardia; 3. 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; 4. Subjects who are ≥18 years of age, and of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subjects meeting guideline indications for cardiac resynchronization therapy (CRT) in the absence of a bradycardia indication; 2. Subjects with a known or suspected sensitivity to dexamethasone acetate (DXA); 3. Subjects with a Mechanical Tricuspid Valve; 4. Subjects requiring hemodialysis or peritoneal dialysis; 5. 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; 6. Subjects currently on an active organ transplant list; 7. Subject referred to or admitted for hospice care; 8. Subjects with a documented life expectancy of less than 12 months; 9. Subjects enrolled in any other concurrent study (unless prior approval is received from the Sponsor); 10. Subjects who are, or plan to become pregnant during the course of the study or are breastfeeding at time of enrollment; 11. 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.
Contact & Investigator
Aurélien Wauters, MD, PhD
PRINCIPAL INVESTIGATOR
Clinique St-Pierre Ottignies
Frequently Asked Questions
Who can join the NCT07209852 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07209852 currently recruiting?
Yes, NCT07209852 is actively recruiting participants. Contact the research team at septa_pmcf@bsci.com for enrollment information.
Where is the NCT07209852 trial being conducted?
This trial is being conducted at Bruges, Belgium, Brussels, Belgium, Lille, France, Paris, France and 9 additional locations.
Who is sponsoring the NCT07209852 clinical trial?
NCT07209852 is sponsored by Boston Scientific Corporation. The principal investigator is Aurélien Wauters, MD, PhD at Clinique St-Pierre Ottignies. The trial plans to enroll 140 participants.