Aortic StenosisNCT06055751
Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
An observational study of Aortic Stenosis and Atrial Fibrillation New Onset, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block
- What is being tested?
- TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2023to Dec 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) as standard of care for arrhyhtmia monitoring after TAVI procedure 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Research Medical Center Clinic
Kansas City, Missouri, 64032
Donita Atkins, 816-651-1969, Datkins@kchrf.com
Naga Venkata K. Pothineni, MD
- Recruiting
Research Medical Center
Kansas City, Missouri, 64032
Donita Atkins, 816-651-1969, Datkins@kchrf.com
Naga Venkata K. Pothineni, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block
- Being tested
- TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)
- Medical subject headings
- Aortic Valve Stenosis, Heart Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)Device
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of brady arrhythmias
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
Measured: 12 Months
Predictors of development of late onset heart block needing pacing
Evaluate predictors of development of late onset (>30 days) heart block needing pacing
Measured: 12 Months
New onset Atrial Fibrillation
Assess the incidence of new onset atrial fibrillation post TAVI
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 Sep 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naga Venkata K. Pothineni, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055751
- Sponsor's protocol ID
- KCHRRF-LUX TAVR-0019
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Massoullie G, Ploux S, Souteyrand G, Mondoly P, Pereira B, Amabile N, Jean F, Irles D, Mansourati J, Combaret N, Mechulan A, Badoz M, Da Costa A, Defaye P, Motreff P, Clerfond G, Bordachar P, Eschalier R. Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study. Heart Rhythm. 2023 May;20(5):699-706. doi: 10.1016/j.hrthm.2023.01.013. Epub 2023 Jan 13.
PubMed 36646235Lilly SM, Deshmukh AJ, Epstein AE, Ricciardi MJ, Shreenivas S, Velagapudi P, Wyman JF. 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. J Am Coll Cardiol. 2020 Nov 17;76(20):2391-2411. doi: 10.1016/j.jacc.2020.08.050. Epub 2020 Oct 21.
PubMed 33190683
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
- ClinicalTrials.gov ID
- NCT06055751
- Acronym / sponsor ID
- KCHRRF-LUX TAVR-0019
- Conditions
- Aortic Stenosis, Atrial Fibrillation New Onset, Heart Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder | – | Device: TAVR Procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473)This is a group of patients who have undergone TAVI procedure and implantation of Boston Scientific Loop Recorder (LUX-Dx PMA# K193473). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone Boston Scientific Loop Recorder (LUX-Dx PMA# K193473) as standard of care for arrhyhtmia monitoring after TAVI procedure 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Transcatheter aortic valve replacement (TAVR) with Boston Scientific Loop Recorder |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 36646235Massoullie G, Ploux S, Souteyrand G, Mondoly P, Pereira B, Amabile N, Jean F, Irles D, Mansourati J, Combaret N, Mechulan A, Badoz M, Da Costa A, Defaye P, Motreff P, Clerfond G, Bordachar P, Eschalier R. Incidence and management of atrioventricular conduction disorders in new-onset left bundle branch block after TAVI: A prospective multicenter study. Heart Rhythm. 2023 May;20(5):699-706. doi: 10.1016/j.hrthm.2023.01.013. Epub 2023 Jan 13.
- Background: PubMed 33190683Lilly SM, Deshmukh AJ, Epstein AE, Ricciardi MJ, Shreenivas S, Velagapudi P, Wyman JF. 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. J Am Coll Cardiol. 2020 Nov 17;76(20):2391-2411. doi: 10.1016/j.jacc.2020.08.050. Epub 2020 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naga Venkata K. Pothineni, MD principal investigator
Kansas City Heart Rhythm Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Atrial Fibrillation New Onset, run by Kansas City Heart Rhythm Research Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of brady arrhythmias (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.