Heart FailureDETECT PSNCT01233323
Detection of Phrenic Nerve Stimulation Using Sensors' Signals
An observational study of Heart Failure, run by Boston Scientific Corporation at 1 site in Germany.
Trial summary
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2010to Mar 2012
- 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 implanted with a COGNIS™ CRT-D device
Who may be able to join
- Willing and capable of providing informed consent and of participating in all testing
- Age 18 or above or of legal age to give informed consent specific to national law
- Implanted with a Boston Scientific COGNIS™ family device
- Geographically stable and is available for follow-up procedures at a study centre
Who cannot join
- Patients that are pacemaker-dependent
- Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
- Patients who are not expected to support approximately 30 minutes of study testing procedures
- Patients who are not mentally competent enough to provide feedback on PS during study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study
The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
- Conditions
- Heart Failure
- Keywords
- Phrenic nerve stimulation, Cardiac Resynchronization Therapy, Heart Failure, Heart Diseases
- Medical subject headings
- Heart Failure, Heart Diseases
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 |
|---|---|---|
| All study patients (single arm study) | All eligible patients will be included in the only study arm and will undergo study testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection
Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Glikson, MD, Principal investigator, Heart Institute, Sheba Medical Center, Tel Hashomer, Israël
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233323
- Sponsor's protocol ID
- DETECT PS
- Acronym
- DETECT PS
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2010
- Last updated
- 3 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study
- ClinicalTrials.gov ID
- NCT01233323
- Acronym / sponsor ID
- DETECT PS / DETECT PS
- Conditions
- Heart Failure
- Keywords
- Phrenic nerve stimulation, Cardiac Resynchronization Therapy, Heart Failure, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Nov 2010 (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 purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study patients (single arm study) | – | –All eligible patients will be included in the only study arm and will undergo study testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients implanted with a COGNIS™ CRT-D device
Key inclusion criteria (4 listed)
- Willing and capable of providing informed consent and of participating in all testing
- Age 18 or above or of legal age to give informed consent specific to national law
- Implanted with a Boston Scientific COGNIS™ family device
- Geographically stable and is available for follow-up procedures at a study centre
Key exclusion criteria (5 listed)
- Patients that are pacemaker-dependent
- Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
- Patients who are not expected to support approximately 30 minutes of study testing procedures
- Patients who are not mentally competent enough to provide feedback on PS during study procedures
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
Data collection
Time frame: 3 months follow up
Collect sensor data in patients with implanted CRT-D devices who exhibit phrenic nerve stimulation.
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 3 Feb 2017.
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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
Heart Institute, Sheba Medical Center, Tel Hashomer, Israël
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 Heart Failure, run by Boston Scientific Corporation at 1 site in Germany.
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 4 inclusion and 5 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 3 Feb 2017. 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 Germany. 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?
Data collection (time frame: 3 months follow up). 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 3 Feb 2017.