Hypertrophic CardiomyopathyNCT03182153
Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by Atlantic Health System at 1 site in United States.
Trial summary
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Extended Cardiac Monitoring
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 31 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any HCM patient followed in the Chanin T. Mast HCM Center at Morristown Medical Center, Morristown, NJ, who is prescribed holter monitoring for risk stratification for SD.
Who may be able to join
- Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center
Who cannot join
- Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Medical Center
Morristown, New Jersey, 07960
About this study
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.
Read the detailed description
Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had.
Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Extended Cardiac Monitoring
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended Cardiac MonitoringDevice
Also called Medtronic SEEQ™ Mobile Cardiac Telemetry
Extended External Cardiac Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Enrolled subjects | Subjects who are diagnosed with HCM and require routine extended cardiac monitoring for risk stratification of sudden cardiac death. All subjects will receive 28 days of external cardiac monitoring. Receives: Device: Extended Cardiac Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Stratification for sudden death (SD)
We aim to determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of non-sustained ventricular tachycardia (NSVT) compared to conventional shorter monitoring periods (48 hours), and thereby potentially identify a subset of HCM patients who may be at higher risk of SD and benefit from a primary prevention implantable cardioverter-defibrillator (ICD) .
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Detection of Atrial Fibrillation
To determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of symptomatic (or asymptomatic) atrial fibrillation compared to conventional shorter monitoring periods (48 hours), and thereby identify a subset of HCM patients who may be at higher risk of symptom progression and stroke.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study startNov 2016
- Primary completion28 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182153
- Sponsor's protocol ID
- SEEQ
- Status last verified
- Jun 2018
- First submitted
- 30 May 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Ambulatory Monitoring Improves Risk Stratification in Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT03182153
- Acronym / sponsor ID
- SEEQ
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 28 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 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.
Eligible subjects will wear 4 consecutive external monitoring devices for a total of 28 days of monitoring.
Detailed description
Eligible subjects will be monitored with a SEEQ device. The SEEQ device is a patch-like device that is worn externally on the chest and continuously monitors heart rhythm. Each device is worn for seven days and replaced with additional devices for a total of 28 days of monitoring. Subjects will return the SEEQ equipment at the end of the monitoring period. Subjects will be contacted by telephone or seen at the clinic approximately 60 days from the first day of monitoring. Information will be gathered about medications and any cardiac interventions the subject may have had.
Subjects will again be contacted by telephone or seen in the clinic approximately 1 year from study start. Information will be gathered about general health, changes in medications, and cardiac interventions or events. Cardiac testing results will be reviewed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled subjects | – | Device: Extended Cardiac MonitoringSubjects who are diagnosed with HCM and require routine extended cardiac monitoring for risk stratification of sudden cardiac death. All subjects will receive 28 days of external cardiac monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any HCM patient followed in the Chanin T. Mast HCM Center at Morristown Medical Center, Morristown, NJ, who is prescribed holter monitoring for risk stratification for SD.
Key inclusion criteria (1 listed)
- Clinical diagnosis of HCM Scheduled for routine ambulatory monitoring for risk stratification Followed at the Chanin T. Mast HCM Center at Morristown Medical Center
Key exclusion criteria (1 listed)
- Prior implantation of an ICD History of persistent/permanent atrial fibrillation (AF)
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 |
|---|---|---|
| Extended Cardiac MonitoringAlso: Medtronic SEEQ™ Mobile Cardiac TelemetryExtended External Cardiac Monitoring | Device | Enrolled subjects |
Primary outcome
Risk Stratification for sudden death (SD)
Time frame: Through study completion, an average of 1 year.
We aim to determine if longer term monitoring (28 days) with the Medtronic SEEQ MCT device identifies a greater burden of non-sustained ventricular tachycardia (NSVT) compared to conventional shorter monitoring periods (48 hours), and thereby potentially identify a subset of HCM patients who may be at higher risk of SD and benefit from a primary prevention implantable cardioverter-defibrillator (ICD) .
1 secondary outcome
Detection of Atrial Fibrillation
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertrophic Cardiomyopathy, run by Atlantic Health System 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 1 inclusion and 1 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 27 Jun 2018. 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?
Results are not available in the source record.
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?
Risk Stratification for sudden death (SD) (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018.