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

Sponsor: Boston Scientific Corporation

NCT ID: NCT07209852

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pacemaker lead (device)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
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).
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
140
Started
2025-12-19
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for bradycardia
  • • Clinical study - 140 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with bradycardia

Where?

  • • Redhill - East Surrey Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

BradycardiaAtrioventricular BlockSinus Node DysfunctionBundle-Branch Block

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ restoration of AV synchrony, including varying degrees of AV block,

What the study is looking for

  • ✓causing symptoms paroxysmal or permanent second- or third-degree AV block,
  • ✓causing symptoms bilateral bundle branch block,
  • ✓causing symptoms paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e.,...
  • ✓Bradycardia-tachycardia syndrome, to prevent causing symptoms bradycardia or some forms of causing symptoms tachyarrhythmias,
  • ✓Neurovascular (vasovagal) syndromes or hypersensitive carotid sinus syndromes,

Who cannot take part

  • ✗Subjects meeting guideline indications for heart resynchronization therapy (CRT) in the absence of a bradycardia...
  • ✗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...
See the full 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.

Where Is This Study? (1 UK site)

East Surrey Hospital

Redhill RH1 5RH, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Jens Goetzke, Dipl.-Ing. (FH)

Sponsor contact

CONTACT

800-227-3422 septa_pmcf@bsci.com

Gena Kantor, MPH

Sponsor contact

CONTACT

800-227-3422 septa_pmcf@bsci.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10