Long-term monitoring of heart rhythm issues after aortic valve replacement

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

This study is testing how heart rhythm problems develop over time in patients with severe aortic stenosis after they have a new heart valve put in, to see how it affects their long-term heart health.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kansas City Heart Rhythm Research Foundation (other)
• Locations: 2 sites (Kansas City, Missouri and 1 other locations)
• Trial ID: NCT06055751 on ClinicalTrials.gov

What this trial studies

The LOCATE Registry aims to monitor patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) and develop new conduction system abnormalities that do not require urgent pacemaker implantation. This observational study will assess the incidence of late-onset heart block and new onset atrial fibrillation following the procedure. Patients will be monitored using a Boston Scientific Loop Recorder for up to 12 months to gather long-term data on their cardiac health and inform future treatment strategies. The study addresses a gap in knowledge regarding the management of these patients and the long-term outcomes of TAVI.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with severe aortic stenosis who develop specific conduction system abnormalities after TAVI.

Not a fit: Patients who require urgent pacemaker implantation or have existing cardiac devices will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with aortic stenosis and conduction system abnormalities.

How similar studies have performed: While some studies have explored short-term arrhythmias post-TAVI, this long-term monitoring approach is relatively novel and untested.

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 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

Where this trial is running

Kansas City, Missouri and 1 other locations

• Research Medical Center Clinic — Kansas City, Missouri, United States (RECRUITING)
• Research Medical Center — Kansas City, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Naga Venkata K. Pothineni, MD — Kansas City Heart Rhythm Institute
• Study coordinator: Donita Atkins

Conditions: Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block