NCT06055751 Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
| NCT ID | NCT06055751 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kansas City Heart Rhythm Research Foundation |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-22 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-09-22 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Naga Venkata K. Pothineni, MD
PRINCIPAL INVESTIGATOR
Kansas City Heart Rhythm Institute
Frequently Asked Questions
Who can join the NCT06055751 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06055751 currently recruiting?
Yes, NCT06055751 is actively recruiting participants. Contact the research team at datkins@kchrf.com for enrollment information.
Where is the NCT06055751 trial being conducted?
This trial is being conducted at Kansas City, United States, Kansas City, United States.
Who is sponsoring the NCT06055751 clinical trial?
NCT06055751 is sponsored by Kansas City Heart Rhythm Research Foundation. The principal investigator is Naga Venkata K. Pothineni, MD at Kansas City Heart Rhythm Institute. The trial plans to enroll 50 participants.