Long-Term Monitoring After Heart Valve Replacement
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Recruiting
Observational Study
Aortic StenosisAtrial Fibrillation New OnsetHeart Block
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Kansas City Heart Rhythm Research Foundation · Other
Who this trial is looking for
This trial is looking for adults with severe aortic stenosis who have had a specific heart procedure and developed new heart rhythm issues. Participants will be monitored over a long period to assess their heart health.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have severe aortic stenosis.
I have undergone trans-catheter aortic valve implantation (TAVI).
I have new heart rhythm issues detected after the procedure.
I have had a long-term monitor implanted for these issues.
You may not be able to join if
I need a pacemaker due to serious heart block after TAVI.
I have an existing heart device implanted.
I cannot have a subcutaneous implanted device due to my medical condition.
I am currently pregnant.
I do not want to sign consent to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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) impla…
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.
Trial Locations
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Eligibility Criteria
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 m…
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
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