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.

Conditions

• Bradycardia
• Right Ventricular Pacing
• Heart Failure
• Atrial Fibrillation (AF)
• Cardiac Disease
• Left Bundle Branch Area Pacing
• Conduction System Pacing

Intervention / Treatment

• Device: LBBAP lead

Primary Outcome Measures

• 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, Italy, Malaysia, Singapore, Spain, United Arab Emirates

Locations and Investigators

• Instituto Nacional de Cardiologia (INC), Rio de Janeiro, Brazil (Not yet recruiting)
  • Helena Rey
  • Rodrigo Minati Barbosa (Principal Investigator)
• Instituto do Coracao (InCor) - HCFMUSP, São Paulo, Brazil (Not yet recruiting)
  • Amanda Alves de Brito
  • Martino Martinelli Filho (Principal Investigator)
• Hopital d'adulte de la Timone, Marseille, France (Recruiting)
  • Caroline Brunet
  • Jean-Claude Deharo (Principal Investigator)
• Kerckhoff-Klinik gGmbH, Bad Nauheim, Germany (Recruiting)
  • Annerose Peil
  • Andreas Hain (Principal Investigator)
• Narayana Institute of Cardiac Sciences, Bommasandra, Bangalore, India (Recruiting)
  • Rani Punitha
  • Kapil Kumawat (Principal Investigator)
• Fortis Escorts Heart Institute, New Delhi, India (Recruiting)
  • Research Coordinator
  • Aparna Jaswal (Principal Investigator)
• Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi, India (Recruiting)
  • Raj K Bipin
  • Isser Hermohander Singh (Principal Investigator)
• Meenakshi Mission Hospital & Research Centre, Madurai, India (Recruiting)
  • Research Coordinator
  • P Jayapandian (Principal Investigator)
• Manipal Hospital E.M. Bypass, Kolkata, India (Recruiting)
  • Shirshendu Debnath
  • Dilip Kumar (Principal Investigator)
• Az.Osp. Universitaria di Ferrara, Cona, Italy (Recruiting)
  • Elisa Mosele
  • Matteo Bertini (Principal Investigator)
• Institut Jantung Negara, Kuala Lumpur, Malaysia (Recruiting)
  • Lydia Yati Munir
  • Azlan Hussin (Principal Investigator)
• Tan Tock Seng Hospital, Singapore, Singapore (Recruiting)
  • Sheau Tyug Wong
  • David Chee Guan Foo (Principal Investigator)
• Changi General Hospital, Singapore, Singapore (Recruiting)
  • Genevieve Pan Jing Wen
  • Vern Hsen Tan (Principal Investigator)
• Hospital Universitario Doce de Octubre, Madrid, Spain (Recruiting)
  • Sofia Barbado Nieto
  • Luis Borrego Bernabe (Principal Investigator)
• Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates (Recruiting)
  • John Rickard