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New treatment option for Bradycardia
Official title Left Bundle Branch Area Pacing (LBBAP) PMCF Study
ClinicalTrials.gov ID: NCT07217392
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
- Are ≥ 18 years of age or age of legal consent, whichever age is greater.
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and...
- Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent...
You likely can't join if
- Patient meets a standard contraindication for lead implant including:
- the presence of tricuspid atresia
- patients with mechanical tricuspid valves
- patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
- Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
- Patient has had a previous unsuccessful attempt to place a lead in the LBB area
See the full eligibility criteria
- Meets current clinical practice guidelines for implantation of Tendril STS 2088TC or UltiPace LPA1231 lead in the Left Bundle Branch Area
- Are ≥ 18 years of age or age of legal consent, whichever age is greater.
- Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
- 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.
- Patient meets a standard contraindication for lead implant including:
- the presence of tricuspid atresia
- patients with mechanical tricuspid valves
- patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate
- Patient is currently implanted with a pacemaker, ICD, or CRT-D/P device
- Patient has had a previous unsuccessful attempt to place a lead in the LBB area
- Patient has planned cardiac surgical procedures or treatment measures within 3 months after implant
- Patient is expected to receive a heart transplant within 6 months
- Patient life expectancy less than 6 months
- Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
- Patient is enrolled or planning to enroll in another clinical trial that might confound the results of the present study
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Rio de Janeiro, Rio de Janeiro, Brazil
- São Paulo, São Paulo, Brazil
- Marseille, Alpes, France
- Bad Nauheim, Hesse, Germany
- Bangalore, Karnakt, India
- New Delhi, National Capital Territory of Delhi, India
- Madurai, Tamil Nadu, India
- Kolkata, West Bengal, India
- Kuala Lumpur, Cmalays, Malaysia
- Singapore, Central, Singapore
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rio de Janeiro, Rio de Janeiro, Brazil; São Paulo, São Paulo, Brazil; Marseille, Alpes, France; Bad Nauheim, Hesse, Germany; Bangalore, Karnakt, India; New Delhi, National Capital Territory of Delhi, India and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.