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โ† Trials
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Left Bundle Branch Area Pacing (LBBAP) PMCF Study

RecruitingNAAges 18 Years - anyAllAbbott Medical Devices
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In plain words

What the trial is, and whether it could suit you

The objective of this study is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients implanted with the Tendril STS 2088TC or UltiPace LPA1231 lead through 6 months post-implant.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area 2. Are โ‰ฅ 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. Patient meets a standard contraindication for lead implant including: 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.
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What it tests

  • LBBAP lead
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Where

15 sites
Instituto Nacional de Cardiologia (INC)
Rio de Janeiro, Brazil
Instituto do Coracao (InCor) - HCFMUSP
Sรฃo Paulo, Brazil
Hopital d'adulte de la Timone
Marseille, France
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, India
Fortis Escorts Heart Institute
New Delhi, India
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi, India
Meenakshi Mission Hospital & Research Centre
Madurai, India

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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