Heart FailureNCT02191696
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
An observational study of Heart Failure, run by Intersection Medical, Inc. at 2 sites in United States.
Trial summary
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- IMED-4 recording
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Jan 2015
- 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 who present for CRM device follow-up are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
Who may be able to join
- Subjects with an active implantable CRM device
- Subjects > 18 years of age
- Subjects who are ambulatory not requiring assistance for ambulation
- Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB
Who cannot join
- Subjects who are pregnant or lactating or who have been pregnant within the past three months
- Subjects who have tattoos on the back in the electrode patch placement region
- Subjects who have had a past allergic reaction to adhesives
- Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Coast Cardiology
Encinitas, California, 92024
Desert Heart
Palm Springs, California, 92262
About this study
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
Read the detailed description
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.
- Conditions
- Heart Failure
- Being tested
- IMED-4 recording
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMED-4 recordingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
IMED-4 recordings
The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015
- Study completionJan 2015
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.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersection Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191696
- Sponsor's protocol ID
- CP-000050
- Status last verified
- Jan 2015
- First submitted
- 14 Jul 2014
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
- ClinicalTrials.gov ID
- NCT02191696
- Acronym / sponsor ID
- CP-000050
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Intersection Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Jul 2014 (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 is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
Detailed description
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present for CRM device follow-up are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.
Key inclusion criteria (4 listed)
- Subjects with an active implantable CRM device
- Subjects > 18 years of age
- Subjects who are ambulatory not requiring assistance for ambulation
- Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB
Key exclusion criteria (4 listed)
- Subjects who are pregnant or lactating or who have been pregnant within the past three months
- Subjects who have tattoos on the back in the electrode patch placement region
- Subjects who have had a past allergic reaction to adhesives
- Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
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 |
|---|---|---|
| IMED-4 recording | Device | – |
Primary outcome
IMED-4 recordings
Time frame: 6 months
The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.
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 30 Jan 2015.
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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.
2 sites 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 Intersection Medical, Inc. at 2 sites 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 4 inclusion and 4 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
IMED-4 recordings (time frame: 6 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 30 Jan 2015.