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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Fortis Escorts Heart Institute
New Delhi, National Capital Territory of Delhi, India
RECRUITINGMeenakshi Mission Hospital & Research Centre
Madurai, Tamil Nadu, India
RECRUITINGInfection Rate
Rate of Infection
Time frame: 0-6 months
Perforation Rate
Perforation includes cardiac perforation, septal perforation, coronary sinus dissection, pericardial effusion, and cardiac tamponade.
Time frame: 0-6 months
Malfunction Rate
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.
Time frame: 0-6 months
Cardiovascular Injury Rate
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).
Time frame: 0-6 months
Implant success rate
Rate of Implant success of LBBAP lead
Time frame: At the time of implant
Lead dislodgement rate
Rate of LBBAP lead dislodgement
Time frame: 0-6 months
Pacing threshold
Measure of minimum electrical energy required to stimulate and depolarize
Time frame: 0-6 months
Impedence
Measure of lead impedance
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Time frame: 0-6 months
Sensing Amplitude
Measure of lead sensing amplitude
Time frame: 0-6 months