Premature Ventricular ComplexesSVT MorphologyNCT00888667
Optimal EGM Configuration for Morphology Discrimination
An observational study of Premature Ventricular Complexes, run by Abbott Medical Devices at 1 site in Canada.
Trial summary
The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site. Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Complexes
- What is being tested?
- Pacing interventions
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to May 2010
- 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 a dual chamber ICD and frequent PVCs
Who may be able to join
- Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
- Patients must be willing to sign an informed consent form.
- Patients must have frequent PVCs (minimum of 30/hour)
Who cannot join
- Known history of slow VT (under 160 bpm).
- Patients under the age of 18 years.
- Pregnant women.
- Pacemaker dependent rhythm.
- Ongoing angina pectoris.
- Current NYHA Class 3-4 heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.
Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.
- Conditions
- Premature Ventricular Complexes
- Being tested
- Pacing interventions
- Keywords
- ICD patients with PVCs and EGM recordings
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacing interventionsOther
10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting
| Study group | Role | What they receive |
|---|---|---|
| ICD patient with frequent PVCs | Not described Receives: Other: Pacing interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
% morphology match
off line analysis
Measured: acute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionMay 2010
Why it stopped: Patient population was not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888667
- Sponsor's protocol ID
- HV001
- Acronym
- SVT Morphology
- Status last verified
- Feb 2019
- First submitted
- 24 Apr 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal EGM Configuration for Morphology Discrimination
- ClinicalTrials.gov ID
- NCT00888667
- Acronym / sponsor ID
- SVT Morphology / HV001
- Conditions
- Premature Ventricular Complexes
- Keywords
- ICD patients with PVCs and EGM recordings
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient population was not available
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Unity Health Toronto
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Apr 2009 (estimated)
- 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 study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.
Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD patient with frequent PVCs | – | Other: Pacing interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a dual chamber ICD and frequent PVCs
Key inclusion criteria (3 listed)
- Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
- Patients must be willing to sign an informed consent form.
- Patients must have frequent PVCs (minimum of 30/hour)
Key exclusion criteria (6 listed)
- Known history of slow VT (under 160 bpm).
- Patients under the age of 18 years.
- Pregnant women.
- Pacemaker dependent rhythm.
- Ongoing angina pectoris.
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 |
|---|---|---|
| Pacing interventions10 seconds recording of atrial paced rhythm at 100 ppm in sitting 10 seconds recording of atrial paced rhythm at 150 ppm in supine 10 seconds recording of atrial paced rhythm at 150 ppm in sitting | Other | ICD patient with frequent PVCs |
Primary outcome
% morphology match
Time frame: acute
off line analysis
Results and safety
The study was stopped early (reason given: Patient population was not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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 Premature Ventricular Complexes, run by Abbott Medical Devices at 1 site in Canada.
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 6 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: stopped early, as of the sponsor's last update on 4 Feb 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 Canada. 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 was stopped early (reason given: Patient population was not available). 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?
% morphology match (time frame: acute). 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 4 Feb 2019.