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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055751
• Other study ID #: KCHRRF-LUX TAVR-0019
• Status: Recruiting
• Start date: September 22, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Clinical management of the patients that develop conduction system abnormalities not severe enough to warrant a PPM implantation is uncertain due to limited prospective long-term data on outcomes in this patient population with significant variations in treatment approaches. While some electrophysiologists favor ambulatory monitoring with event monitors or Implantable loop recorder (ILR), small studies have shown a potential benefit of invasive electrophysiological studies for risk stratification. Most rhythm monitoring studies have only focused on arrhythmias in the first 2-4 weeks post implantation with very sparse data on longer term outcomes. In addition to conduction system abnormalities, other arrhythmias such as AF following TAVI have also been shown to be associated with worse long-term outcomes. However, prospective data on incidence and risk factors of post TAVI atrial fibrillation is limited. This will be a prospective observational study (Registry). Patients that have undergone a TAVI procedure and meet inclusion and no exclusion criteria will be approached about participating in the study. Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx Premarket Approval Application (PMA)# K193473) as standard of care for arrhythmia monitoring after TAVI 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Heart Block

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	New onset Atrial Fibrillation	Assess the incidence of new onset atrial fibrillation post TAVI	12 Months