Recruiting

Observational Study

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06055751

Conditions

Aortic Stenosis

Atrial Fibrillation New Onset

Heart Block

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)

Study Details

Brief summary:

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.

Conditions

Aortic Stenosis

Atrial Fibrillation New Onset

Heart Block

Study ID

NCT06055751

Start date

Sep 22, 2023

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients > 18 years of age with severe aortic stenosis that undergo TAVI for severe aortic stenosis that develop any one of the following conduction system abnormalities on the immediate post procedural or post operative ECG and have undergone ILR implantation for long-term monitoring of these conditions:
  • 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

Exclusion Criteria:

  • 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).
  • Patients not willing to sign the consent, lacks the capacity to sign the consent or revoke the consent after signing will be excluded

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder

This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).

Interventions

TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)

No intervention will be done as part of this prospective registry. Implantation of Boston Scientific Loop Recorder (LUX-Dx) will be performed regardless of this research and outside this research protocol per standard of care

Primary outcome measure

  • Incidence of brady arrhythmias [ Time Frame: 12 Months ]
  • Predictors of development of late onset heart block needing pacing [ Time Frame: 12 Months ]
  • New onset Atrial Fibrillation [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Research Medical Center Clinic

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Naga Venkata K. Pothineni, MD

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64032

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Naga Venkata K. Pothineni, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Oct 16, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2024-10-16.