Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06055751 |
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Recruitment Status :
Recruiting
First Posted : September 28, 2023
Last Update Posted : October 17, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Aortic Stenosis Atrial Fibrillation New Onset Heart Block | Device: TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) |
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.
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 50 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry |
| Actual Study Start Date : | September 22, 2023 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder
This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473).
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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 |
- Incidence of brady arrhythmias [ Time Frame: 12 Months ]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
- Predictors of development of late onset heart block needing pacing [ Time Frame: 12 Months ]Evaluate predictors of development of late onset (>30 days) heart block needing pacing
- New onset Atrial Fibrillation [ Time Frame: 12 Months ]Assess the incidence of new onset atrial fibrillation post TAVI
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055751
| Contact: Donita Atkins | 816-651-1969 | datkins@kchrf.com |
| United States, Missouri | |
| Research Medical Center Clinic | Recruiting |
| Kansas City, Missouri, United States, 64032 | |
| Contact: Donita Atkins 816-651-1969 Datkins@kchrf.com | |
| Principal Investigator: Naga Venkata K. Pothineni, MD | |
| Research Medical Center | Recruiting |
| Kansas City, Missouri, United States, 64032 | |
| Contact: Donita Atkins 816-651-1969 Datkins@kchrf.com | |
| Principal Investigator: Naga Venkata K. Pothineni, MD | |
| Principal Investigator: | Naga Venkata K. Pothineni, MD | Kansas City Heart Rhythm Institute |
| Responsible Party: | Kansas City Heart Rhythm Research Foundation |
| ClinicalTrials.gov Identifier: | NCT06055751 |
| Other Study ID Numbers: |
KCHRRF-LUX TAVR-0019 |
| First Posted: | September 28, 2023 Key Record Dates |
| Last Update Posted: | October 17, 2023 |
| Last Verified: | October 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | No |
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Atrial Fibrillation Arrhythmias, Cardiac Aortic Valve Stenosis Heart Block Heart Diseases Cardiovascular Diseases |
Pathologic Processes Aortic Valve Disease Heart Valve Diseases Ventricular Outflow Obstruction Cardiac Conduction System Disease |