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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (1 UK site)
East Surrey Hospital
Redhill RH1 5RH, United Kingdom
How to Get in Touch
Jens Goetzke, Dipl.-Ing. (FH)
Sponsor contactCONTACT
Gena Kantor, MPH
Sponsor contactCONTACT
