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Recruiting NCT07217392

Left Bundle Branch Area Pacing (LBBAP) PMCF Study

No phase Interventional Bradycardia Right Ventricular Pacing Heart Failure Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LBBAP lead.
Who it may be relevant to
Registry conditions: Bradycardia, Right Ventricular Pacing, Heart Failure, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, France, Germany, India, Malaysia +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

The Left Bundle Branch Area Pacing (LBBAP) Post-Market Clinical Follow-up (PMCF) Study is a global, prospective, single-arm, multi-center trial conducted to support an indication expansion of the Tendril STS (model 2088TC) and UltiPace (model LPA1231) leads to include pacing/sensing in the left bundle branch area (LBBA).

Interventions

  • 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.

Primary outcome measures

  • Infection Rate [Time frame: 0-6 months]
  • Perforation Rate [Time frame: 0-6 months]
  • Malfunction Rate [Time frame: 0-6 months]
  • Cardiovascular Injury Rate [Time frame: 0-6 months]
  • Implant success rate [Time frame: At the time of implant]
  • Lead dislodgement rate [Time frame: 0-6 months]
  • Pacing threshold [Time frame: 0-6 months]
  • Impedence [Time frame: 0-6 months]
  • Sensing Amplitude [Time frame: 0-6 months]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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 interventional 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 subjects 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 investigation or to comply with follow-up requirements of the clinical investigation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

India · 5 centers
  • Narayana Institute of Cardiac Sciences, Bommasandra — Bangalore
  • Fortis Escorts Heart Institute — New Delhi
  • Vardhman Mahavir Medical College & Safdarjung Hospital — New Delhi
  • Meenakshi Mission Hospital & Research Centre — Madurai
  • Manipal Hospital E.M. Bypass — Kolkata
Brazil · 2 centers
  • Instituto Nacional de Cardiologia (INC) — Rio de Janeiro
  • Instituto do Coracao (InCor) - HCFMUSP — São Paulo
Singapore · 2 centers
  • Tan Tock Seng Hospital — Singapore
  • Changi General Hospital — Singapore
France · 1 center
  • Hopital d'adulte de la Timone — Marseille
Germany · 1 center
  • Kerckhoff-Klinik gGmbH — Bad Nauheim
Malaysia · 1 center
  • Institut Jantung Negara — Kuala Lumpur
Spain · 1 center
  • Hospital Universitario Doce de Octubre — Madrid

Identifiers

NCT: NCT07217392 · ABT-CIP-10551

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗