What is this study trying to find out about aortic stenosis and heart rhythm problems after TAVI?

This study is observing how often heart rhythm problems, like late heart block and new atrial fibrillation, occur after TAVI procedures in patients with severe aortic stenosis. The goal is to better understand long-term heart health after TAVI to help improve care. The Kansas City Heart Rhythm Research Foundation is leading this research.

Who may be eligible for this aortic stenosis clinical trial?

Adults aged 18 or older who have severe aortic stenosis and have undergone TAVI with certain new conduction abnormalities may be eligible. The study includes both men and women but excludes patients needing urgent pacemakers or those with existing cardiac devices. Please review eligibility criteria for more details.

Is there any cost to participate in this aortic stenosis clinical trial?

Study-related care, including monitoring with the Boston Scientific Loop Recorder and all trial visits, is provided at no cost. Personal travel or other expenses are not guaranteed to be covered and may vary by participant.

Actively Recruiting

Age: 18Years +

All Genders

ID06055751

Long-Term Monitoring of Heart Rhythm Changes After Transcatheter Aortic Valve Replacement Using Boston Scientific Loop Recorder

Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-16

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are observing patients with severe aortic stenosis who have undergone transcatheter aortic valve implantation TAVI and developed new conduction system abnormalities that do not require urgent permanent pacemaker implantation. The study aims to understand the long-term occurrence of heart block that may need pacemakers later and the development of new atrial fibrillation after TAVI. This research hopes to improve knowledge and treatment for patients with these heart conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients over 18 years old with severe aortic stenosis who have undergone TAVI
Development of new conduction abnormalities after TAVI, including 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
Underwent implantation of Boston Scientific Loop Recorder for long-term monitoring

You will not qualify if you...

Patients requiring urgent permanent pacemaker implantation due to high-grade or complete AV block after TAVI
Patients with existing cardiac implantable electronic devices
Patients unable to tolerate subcutaneous, chronically-inserted devices due to medical conditions
Currently pregnant patients (positive urine Beta-HCG test)
Patients unwilling or unable to provide informed consent or who revoke consent after signing

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 12 months

Participants have a Boston Scientific Loop Recorder implanted as part of their routine care after undergoing transcatheter aortic valve implantation (TAVI).

Monthly monitoring visits

Long-term Monitoring

Duration - Up to 12 months

Participants are monitored for cardiac arrhythmias and conduction abnormalities through the implanted loop recorder, with monthly reviews by the electrophysiology team.

Monthly visits for device monitoring and evaluation

Research Team

Donita Atkins

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

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Frequently Asked Questions

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Published Research Related To This Trial

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.

Scott M Lilly, Abhishek J Deshmukh, Andrew E Epstein...

https://pubmed.ncbi.nlm.nih.gov/33190683/

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

Grégoire Massoullié, Sylvain Ploux, Géraud Souteyrand...

https://pubmed.ncbi.nlm.nih.gov/36646235/

Long-Term Monitoring of Heart Rhythm Changes After Transcatheter Aortic Valve Replacement Using Boston Scientific Loop Recorder

On this page

Sponsors

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Your Study Journey

Research Team

How is the study designed?

Similar Trials

Study of Pelacarsen TQJ230 Given Monthly by Injection to Slo...

Study of Using the ABC Bicuspid Sizing Algorithm to Guide Va...

Study of an Artificial Intelligence Model to Identify Severe...

Frequently Asked Questions

What is this study trying to find out about aortic stenosis and heart rhythm problems after TAVI?

Who may be eligible for this aortic stenosis clinical trial?

Is there any cost to participate in this aortic stenosis clinical trial?

What will I be asked to do in this aortic stenosis study?

How will the study measure heart rhythm problems after TAVI?

What happens after this aortic stenosis clinical trial ends?

Can I leave this aortic stenosis clinical trial if I change my mind?

Not the Right Trial for You?

Published Research Related To This Trial

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.

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

Your Study Journey

How is the study designed?

Similar Trials

Study of Pelacarsen TQJ230 Given Monthly by Injection to Slo...

Study of Using the ABC Bicuspid Sizing Algorithm to Guide Va...

Study of an Artificial Intelligence Model to Identify Severe...

Frequently Asked Questions

What is this study trying to find out about aortic stenosis and heart rhythm problems after TAVI?

Who may be eligible for this aortic stenosis clinical trial?

Is there any cost to participate in this aortic stenosis clinical trial?

What will I be asked to do in this aortic stenosis study?

How will the study measure heart rhythm problems after TAVI?

What happens after this aortic stenosis clinical trial ends?

Can I leave this aortic stenosis clinical trial if I change my mind?

Published Research Related To This Trial

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.

Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study.

Sponsors