TachyarrhythmiaNCT03408951
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
An observational study of Tachyarrhythmia and Arrhythmias, Cardiac, run by NewPace Ltd at 1 site in United States.
Trial summary
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia, Arrhythmias, Cardiac
- What is being tested?
- Recording
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2017to 5 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high chance of having a cardiac tachyarrhythmia
Who may be able to join
- candidate for ICD implantation
- candidate for an ICD DFT study
- candidate for an EP study
Who cannot join
- age <18
Trial locations and contacts
1 site in 1 country.
United States1 site
St Francis Hospital Heart Center
Roslyn, New York, 11576
About this study
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.
Read the detailed description
cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.
- Conditions
- Tachyarrhythmia, Arrhythmias, Cardiac
- Being tested
- Recording
- Medical subject headings
- Tachycardia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecordingOther
The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm
| Study group | Role | What they receive |
|---|---|---|
| Interventions (recording) | Patients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia. Receives: Other: Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISSD algorithm detection rates
Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces
Measured: through study completion, expected at 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start2 Mar 2017
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewPace Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph H Levine, M.D, Principal investigator, St Francis Hospital Heart CenterDavid Hoch, M.D, Principal investigator, St Francis Hospital Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408951
- Sponsor's protocol ID
- NPC03
- Status last verified
- Jan 2018
- First submitted
- 16 Jan 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
- ClinicalTrials.gov ID
- NCT03408951
- Acronym / sponsor ID
- NPC03
- Conditions
- Tachyarrhythmia, Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- NewPace LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 24 Jan 2018 (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.
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.
Detailed description
cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions (recording) | – | Other: RecordingPatients requiring Intracardiac defibrillator (ICD) implantation or Defibrillation Test (DFT) or Electrophysiology (EP) study with high probability of supra ventricular tachyarrhythmia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high chance of having a cardiac tachyarrhythmia
Key inclusion criteria (3 listed)
- candidate for ICD implantation
- candidate for an ICD DFT study
- candidate for an EP study
Key exclusion criteria (1 listed)
- age <18
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 |
|---|---|---|
| RecordingThe patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm | Other | Interventions (recording) |
Primary outcome
ISSD algorithm detection rates
Time frame: through study completion, expected at 15 months
Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces
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 Aug 2019.
- 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.
Joseph H Levine, M.D principal investigator
St Francis Hospital Heart Center
David Hoch, M.D principal investigator
St Francis Hospital Heart Center
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 Tachyarrhythmia and Arrhythmias, Cardiac, run by NewPace Ltd 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 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: finished, as of the sponsor's last update on 21 Aug 2019. 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?
ISSD algorithm detection rates (time frame: through study completion, expected at 15 months). 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 21 Aug 2019.