Atrial Fibrillation (AF), Bradycardia, Cardiac Disease, Conduction System Pacing, Heart Failure, Left Bundle Branch Area Pacing, Right Ventricular Pacing
Conditions
Keywords
Right ventricular pacing, cardiac disease, heart failure, atrial fibrillation, bradycardia, left bundle branch area pacing, conduction system pacing
Brief 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.
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
DEVICELBBAP 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil, France, Germany, India, Malaysia, Singapore, Spain
Contacts
CONTACTClinical Research Scientist
CONTACTClinical Project Manager
Outcome results
None listed