BradycardiaRight Ventricular PacingHeart FailureAtrial Fibrillation (AF)Cardiac DiseaseLeft Bundle Branch Area PacingConduction System Pacing
Investigational drug(s) / intervention(s)
LBBAP lead
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 ≥ 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.
Primary outcome measure(s)
Infection Rate — 0-6 months Rate of Infection
Perforation Rate — 0-6 months Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
Malfunction Rate — 0-6 months Malfunction includes 1) mechanical lead failure including lead insulation issues, lead fracture, and other lead damage, dysfunction, helix damage or fracture; malfunction or failure; and 2) electrical abnormalities of unknown cause including sensing issues, pacing issues, loss of capture, impedance abnormality, and noise; 3) excludes infection, perforation or dislodgement caused inappropriate therapy.
Cardiovascular Injury Rate — 0-6 months Cardiovascular Injury is a safety measure specific to LBBAP leads and includes Acute coronary syndrome; Coronary artery fistula; Coronary vein fistula/injury and Septal hematoma. This parameter also includes the right bundle branch block and complete heart block (permanent).
Implant success rate — At the time of implant Rate of Implant success of LBBAP lead
Lead dislodgement rate — 0-6 months Rate of LBBAP lead dislodgement
Pacing threshold — 0-6 months Measure of minimum electrical energy required to stimulate and depolarize
Impedence — 0-6 months Measure of lead impedance
Sensing Amplitude — 0-6 months Measure of lead sensing amplitude
Trial sites (13)
Facility
City
Region
Status
Instituto Nacional de Cardiologia (INC)
Rio de Janeiro
Rio de Janeiro
Not Yet Recruiting
Instituto do Coracao (InCor) - HCFMUSP
São Paulo
São Paulo
Not Yet Recruiting
Hopital d'adulte de la Timone
Marseille
Alpes
Recruiting
Kerckhoff-Klinik gGmbH
Bad Nauheim
Hesse
Not Yet Recruiting
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore
Karnakt
Recruiting
Fortis Escorts Heart Institute
New Delhi
National Capital Territory of Delhi
Recruiting
Vardhman Mahavir Medical College & Safdarjung Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.