Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry

NCT06055751 | Recruiting FDA Device

• 1 other identifier: KCHRRF-LUX TAVR-0019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Incidence of brady arrhythmias

  Incidence of significant brady arrhythmias (2:1 or higher-grade Atrioventricular block (AV) block) requiring pacemaker implantation post TAVI in patients with evidence of conduction system injury following TAVI

  12 Months

• Predictors of development of late onset heart block needing pacing

  Evaluate predictors of development of late onset (\>30 days) heart block needing pacing

  12 Months

• New onset Atrial Fibrillation

  Assess the incidence of new onset atrial fibrillation post TAVI

  12 Months

Study Arms (1)

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).

Device: TAVR 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) DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) as standard of care for arrhyhtmia monitoring after TAVI procedure will have the ILR monitored monthly by the electrophysiology team. All alerts will be reviewed and discussed with the implanting physician for further management. Patients will be followed for up to 12 months.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (2)

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64032, United States

RECRUITING

Related Publications (2)

• Massoullie G, Ploux S, Souteyrand G, Mondoly P, Pereira B, Amabile N, Jean F, Irles D, Mansourati J, Combaret N, Mechulan A, Badoz M, Da Costa A, Defaye P, Motreff P, Clerfond G, Bordachar P, Eschalier R. Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study. Heart Rhythm. 2023 May;20(5):699-706. doi: 10.1016/j.hrthm.2023.01.013. Epub 2023 Jan 13.

  PMID: 36646235 BACKGROUND

• Lilly SM, Deshmukh AJ, Epstein AE, Ricciardi MJ, Shreenivas S, Velagapudi P, Wyman JF. 2020 ACC Expert Consensus Decision Pathway on Management of Conduction Disturbances in Patients Undergoing Transcatheter Aortic Valve Replacement: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020 Nov 17;76(20):2391-2411. doi: 10.1016/j.jacc.2020.08.050. Epub 2020 Oct 21.

  PMID: 33190683 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Block

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Naga Venkata K. Pothineni, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: September 22, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

US (2)