About this trial
The purpose of the Long term Evaluation of Cardiac Arrhythmias after Transcatheter Aortic Valve Implantation (LOCATE) Registry is to perform long-term ambulatory monitoring of patients with severe aortic stenosis who undergo trans-catheter aortic valve implantation (TAVI) and develop new onset conduction system abnormalities post-procedure that do not require urgent permanent pacemaker (PPM) implantation. The primary objectives of this study are to assess the incidence of late onset heart block necessitating PPM implantation and to evaluate the incidence of new onset atrial fibrillation (AF) following TAVI. This study aims to provide valuable insights into the long-term cardiac health of TAVI patients and inform the development of improved treatment strategies for aortic stenosis patients with conduction system abnormalities.
Eligibility criteria
Qualifiers
New left bundle branch block (QRS >120ms)
New first degree AV block (PR>200ms) or worsening of pre-existing first-degree AV block by >30ms
New right bundle branch block (QRS>120ms)
Intra-procedural 2:1 or higher-grade AV block with spontaneous improvement within 24 hours
Disqualifiers
Patients with high grade or complete AV block post TAVI needing urgent pacemakers
Patient with existing cardiac implantable electronic devices (CIEDs)
Patients having a particular medical condition that dictates that they cannot tolerate subcutaneous, chronically-inserted device
Patient is currently pregnant as evidenced by urine positive Beta-HCG. (Urine Beta human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
Trial design
Treatments tested in this trial
- TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)