Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-07-24
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Left Bundle Branch Area Pacing Lead Implant
Data will be collected from patients implanted with either the Tendril STS 2088TC or UltiPace LPA1231 lead in the left bundle branch area for pacing and sensing from implant through 6 months. Leads are indicated for use in combination with a compatible pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device.
LBBAP lead
The lead is bipolar, steroid-eluting, active fixation, MR Conditional, implantable pacing leads that can be placed in the right atrium, right ventricle, or left bundle branch area for pacing and sensing.
Interventions
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LBBAP lead
The lead is bipolar, steroid-eluting, active fixation, MR Conditional, implantable pacing leads that can be placed in the right atrium, right ventricle, or left bundle branch area for pacing and sensing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Are ≥ 18 years of age or age of legal consent, whichever age is greater.
3. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
4. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
Exclusion Criteria
1. the presence of tricuspid atresia
2. patients with mechanical tricuspid valves
3. patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
2. Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
3. Patient has had a previous unsuccessful attempt to place a lead in the LBB area
4. Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
5. Patient is expected to receive a heart transplant within 6 months
6. Patient life expectancy less than 6 months
7. Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
8. Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
9. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
10. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India
Meenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABT-CIP-10551
Identifier Type: -
Identifier Source: org_study_id
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