BradycardiaNCT03180073
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
An observational study of Bradycardia, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bradycardia
- What is being tested?
- Ziopatch Pre discharge, Ziopatch at Discharge and Ziopatch at 2 months
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 23 Dec 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled
Who may be able to join
- Age > 18 and <90 years old
- Able to provide informed consent
- Willing to follow up at Cleveland Clinic (per TAVR protocol)
Who cannot join
- Prior CIED (Pacemaker or defibrillator)
- Unable to provide consent
- Unable to follow up at Cleveland Clinic per TAVR protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Significance of Bradycardic Arrhythmias and Conduction Abnormalities Among Patients With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement Using Extended Heart Rhythm Recording (Brady-TAVR Study)
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.
Read the detailed description
Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.
Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks
- Conditions
- Bradycardia
- Being tested
- Ziopatch Pre discharge, Ziopatch at Discharge, Ziopatch at 2 months
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziopatch Pre dischargeDiagnostic test
Ziopatch applied 2 weeks prior to procedure
Ziopatch at DischargeDiagnostic test
Ziopatch applied at discharge from hospital to be worn for 2 weeks
Ziopatch at 2 monthsDiagnostic test
Ziopatch applied 2 months from procedure to be worn for 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Pacemaker post TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus Pauses, AV Block, Bundle Branch Block) among patients with severe aortic stenosis who undergo TAVR using an extended cardiac rhythm monitor (Zio Patch) and determine if the brady arrhythmias predict the need for a pacemaker.
Measured: 2 months prior to TAVR
Secondary outcomes (3)
Prevalence of in hospital brady arrhythmia post TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus pause, AV block, Bundle branch block) using hospital telemetry data
Measured: 72 hours post TAVR
Prevalence of brady arrhythmia after discharge from hospital post TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus pauses, AV block, Bundle branch block) using extended cardiac rhythm monitor (Zio Patch)
Measured: 3 weeks post discharge
Prevalence of delayed brady arrhythmia post TAVR
the prevalence of brady arrhythmia using extended cardiac rhythm Assess the prevalence of brady arrhythmia (Sinus brady, Sinus Pause, AV block, Bundle branch block) using extended cardiac rhythm monitor (Zio Patch)
Measured: 2 months post TAVR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start6 Jun 2017
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaldoun Tarakji, The Cleveland Clinic
- Investigators
- Khaldoun Tarakji, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180073
- Sponsor's protocol ID
- 17-086
- Status last verified
- Feb 2021
- First submitted
- 9 May 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarakji KG, Patel D, Krishnaswamy A, Hussein A, Saliba W, Wilkoff BL, Wolski K, Svensson L, Wazni OM, Kapadia SR. Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study). Heart Rhythm. 2022 Mar;19(3):381-388. doi: 10.1016/j.hrthm.2021.11.020. Epub 2021 Nov 18.
PubMed 34801735
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Significance of Bradycardic Arrhythmias and Conduction Abnormalities Among Patients With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement Using Extended Heart Rhythm Recording (Brady-TAVR Study)
- ClinicalTrials.gov ID
- NCT03180073
- Acronym / sponsor ID
- 17-086
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 8 Jun 2017 (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.
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation. Little is known about the prevalence and timing of any conduction abnormalities that exist before (other than standard ECG) or after through long term cardiac monitoring.
Detailed description
Each subject who fulfills the inclusion/exclusion criteria will be provided with Zio patch for 2 weeks before TAVR. Immediately after the procedure, patients will be admitted per TAVR protocol and will be on telemetry. Data about their ECGs and any arrhythmias will be collected.
Upon discharge, patients will be provided with another Zio patch for 2 weeks. At the 2-3 months follow up, subjects will be provided with a third Zio patch for 2 weeks
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be scheduled for TAVR without preexisting Cardiac Implantable Electronic Device (CIED) can be screen and enrolled
Key inclusion criteria (3 listed)
- Age > 18 and <90 years old
- Able to provide informed consent
- Willing to follow up at Cleveland Clinic (per TAVR protocol)
Key exclusion criteria (3 listed)
- Prior CIED (Pacemaker or defibrillator)
- Unable to provide consent
- Unable to follow up at Cleveland Clinic per TAVR protocol
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 |
|---|---|---|
| Ziopatch Pre dischargeZiopatch applied 2 weeks prior to procedure | Diagnostic test | – |
| Ziopatch at DischargeZiopatch applied at discharge from hospital to be worn for 2 weeks | Diagnostic test | – |
| Ziopatch at 2 monthsZiopatch applied 2 months from procedure to be worn for 2 weeks | Diagnostic test | – |
Primary outcome
Need for Pacemaker post TAVR
Time frame: 2 months prior to TAVR
the prevalence of brady arrhythmia (Sinus brady, Sinus Pauses, AV Block, Bundle Branch Block) among patients with severe aortic stenosis who undergo TAVR using an extended cardiac rhythm monitor (Zio Patch) and determine if the brady arrhythmias predict the need for a pacemaker.
3 secondary outcomes
Prevalence of in hospital brady arrhythmia post TAVR
Time frame: 72 hours post TAVR
Prevalence of brady arrhythmia after discharge from hospital post TAVR
Time frame: 3 weeks post discharge
Prevalence of delayed brady arrhythmia post TAVR
Time frame: 2 months post TAVR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 34801735Tarakji KG, Patel D, Krishnaswamy A, Hussein A, Saliba W, Wilkoff BL, Wolski K, Svensson L, Wazni OM, Kapadia SR. Bradyarrhythmias detected by extended rhythm recording in patients undergoing transcatheter aortic valve replacement (Brady-TAVR Study). Heart Rhythm. 2022 Mar;19(3):381-388. doi: 10.1016/j.hrthm.2021.11.020. Epub 2021 Nov 18.
- Individual participant dataSharing planned: No
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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.
Khaldoun Tarakji, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by The Cleveland Clinic at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Pacemaker post TAVR (time frame: 2 months prior to TAVR). 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 NCT03180073, which also lists 1 linked publication.
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 21 Feb 2021.