Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)NCT01605500
Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators
An observational study of Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD), run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the alert tones emitted by the latest generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to patients. ICD patients can have difficulties hearing the beeps, which are designed to notify patients of possible lead or generator malfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 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 have a Generation 2 Medtronic implantable cardioverter-defibrillator (ICD)
Who may be able to join
- Previous insertion of a Medtronic Generation 2 ICD (Consulta, Secura, Concerto II, Virtuoso II, Maximo II devices) not fewer than 7 days prior to study entry
- Able to provide informed consent
Who cannot join
- Known deafness
- Recent (fewer than 6 weeks) ICD pocket surgery
- Non-Generation 2 Medtronic ICD
- Pocket hematoma
- Pocket infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
About this study
Official title: Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs
The purpose of this study is to determine whether the alert tones emitted by the latest generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to patients.
ICD patients can have difficulties hearing the beeps, which are designed to notify patients of possible lead or generator malfunction. In fact, the only published study of this issue, conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with older Medtronic devices were able to hear alerts. Since then, modifications to the alert have been made by Medtronic. This study will establish the "real-world" value of these changes and also provide useful in vivo information regarding the validity of the in vitro techniques which have been used thus far to design the Patient Alert feature.
Read the detailed description
There will be a single study visit. In a quiet examination room, the Patient Alert tones will be demonstrated to the subjects. Subsequently, this will be repeated with a wall air conditioner turned on. The subjects will then be asked to complete a three-part questionnaire regarding their perceptions of the Patient Alert tones.
Data analysis will include overall ability to hear tones, as well as subgroup analysis according to gender, age, and BMI.
Simultaneously, in order to calculate the loudness of the alert tones, digital recordings will be obtained using two microphones located near the subject. These digital recordings will be analyzed, and a loudness value will be calculated. The loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity. Data analysis will include a correlation between loudness value and patient characteristics, and between loudness value and ability of subjects to perceive the tones.
- Keywords
- ICD
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 |
|---|---|---|
| Medtronic ICDs | Patients with Generation 2 Medtronic ICDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audibility
how frequently patients are able to detect the alert tones
Measured: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes
Secondary outcomes (1)
Loudness value
digital recordings of the tones will be analyzed to determine the loudness value
loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD)Studies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Grant Simons, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605500
- Sponsor's protocol ID
- E-12-445
- Status last verified
- Feb 2016
- First submitted
- 18 May 2012
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Simons EC, Feigenblum DY, Nemirovsky D, Simons GR. Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol. 2009 Oct;32(10):1272-5. doi: 10.1111/j.1540-8159.2009.02480.x. Epub 2009 Aug 18.
PubMed 19691679
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Utility of the Audible Alert in Current Generation Medtronic ICDs
- ClinicalTrials.gov ID
- NCT01605500
- Acronym / sponsor ID
- E-12-445
- Keywords
- ICD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 May 2012 (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 determine whether the alert tones emitted by the latest generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to patients.
ICD patients can have difficulties hearing the beeps, which are designed to notify patients of possible lead or generator malfunction. In fact, the only published study of this issue, conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with older Medtronic devices were able to hear alerts. Since then, modifications to the alert have been made by Medtronic. This study will establish the "real-world" value of these changes and also provide useful in vivo information regarding the validity of the in vitro techniques which have been used thus far to design the Patient Alert feature.
Detailed description
There will be a single study visit. In a quiet examination room, the Patient Alert tones will be demonstrated to the subjects. Subsequently, this will be repeated with a wall air conditioner turned on. The subjects will then be asked to complete a three-part questionnaire regarding their perceptions of the Patient Alert tones.
Data analysis will include overall ability to hear tones, as well as subgroup analysis according to gender, age, and BMI.
Simultaneously, in order to calculate the loudness of the alert tones, digital recordings will be obtained using two microphones located near the subject. These digital recordings will be analyzed, and a loudness value will be calculated. The loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity. Data analysis will include a correlation between loudness value and patient characteristics, and between loudness value and ability of subjects to perceive the tones.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medtronic ICDs | – | –Patients with Generation 2 Medtronic ICDs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have a Generation 2 Medtronic implantable cardioverter-defibrillator (ICD)
Key inclusion criteria (2 listed)
- Previous insertion of a Medtronic Generation 2 ICD (Consulta, Secura, Concerto II, Virtuoso II, Maximo II devices) not fewer than 7 days prior to study entry
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Known deafness
- Recent (fewer than 6 weeks) ICD pocket surgery
- Non-Generation 2 Medtronic ICD
- Pocket hematoma
- Pocket infection
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
Audibility
Time frame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes
how frequently patients are able to detect the alert tones
1 secondary outcome
Loudness value
Time frame: 1 month
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 Feb 2016.
- Background: PubMed 19691679Simons EC, Feigenblum DY, Nemirovsky D, Simons GR. Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol. 2009 Oct;32(10):1272-5. doi: 10.1111/j.1540-8159.2009.02480.x. Epub 2009 Aug 18.
- Site informationLink provided by the sponsor.
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.
Grant Simons, MD principal investigator
Englewood Hospital and Medical 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 Patients With a Generation 2 Medtronic Implantable Cardioverter-defibrillator(ICD), run by Englewood Hospital and Medical Center 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 2 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 19 Feb 2016. 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?
Audibility (time frame: participants will be tested during a single, routine clinic visit - the average duration for each patient will be 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01605500, which also lists 1 linked publication.
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 Feb 2016.