Ventricular TachyarrhythmiaHRVNCT00701467
Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients
An observational study of Ventricular Tachyarrhythmia, run by Sheba Medical Center at 1 site in Israel.
Trial summary
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventricular Tachyarrhythmia
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2008to Mar 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ICD clinic
Who may be able to join
- S/P lexos VR/-T,DR/-T implantation
- Signed patient informed consent
Who cannot join
- CAF
- Life expectancy<6 months
- Impending heart transplant
- Persistent recurring tachycardia
- Rhythm disturbances that preclude a meaningful HRV analysis
- Participation in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.
- Conditions
- Ventricular Tachyarrhythmia
- Keywords
- ICD, ICD implanted patients
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RR interval recorded by ICD
Measured: within an hour before ventricular tachyarrythmia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachyarrhythmiaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Michael Glikson, Sheba Medical Center
- Investigators
- Michael Glikson, MD, Principal investigator, SHEBA MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701467
- Sponsor's protocol ID
- SHEBA-4743-07-MG-CTIL
- Acronym
- HRV
- Status last verified
- Nov 2013
- First submitted
- 18 Jun 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia
- ClinicalTrials.gov ID
- NCT00701467
- Acronym / sponsor ID
- HRV / SHEBA-4743-07-MG-CTIL
- Conditions
- Ventricular Tachyarrhythmia
- Keywords
- ICD, ICD implanted patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Jun 2008 (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.
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICD clinic
Key inclusion criteria (2 listed)
- S/P lexos VR/-T,DR/-T implantation
- Signed patient informed consent
Key exclusion criteria (6 listed)
- CAF
- Life expectancy<6 months
- Impending heart transplant
- Persistent recurring tachycardia
- Rhythm disturbances that preclude a meaningful HRV analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in RR interval recorded by ICD
Time frame: within an hour before ventricular tachyarrythmia
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 19 Nov 2013.
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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.
Michael Glikson, MD principal investigator
SHEBA MC
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 Ventricular Tachyarrhythmia, run by Sheba Medical Center at 1 site in Israel.
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 2 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: finished, as of the sponsor's last update on 19 Nov 2013. 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 Israel. 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?
Change in RR interval recorded by ICD (time frame: within an hour before ventricular tachyarrythmia). 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 19 Nov 2013.