Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT DeviceNCT02095977
Insulation Failure in St. Jude Riata Leads
A study testing fluoroscopy, synchronized high-voltage shock and Holter monitor in people with Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device and to Which is Attached a St. Jude Riata Lead, run by Hartford Hospital at 1 site in United States.
Trial summary
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device, to Which is Attached a St. Jude Riata Lead
- What is being tested?
- fluoroscopy, synchronized high-voltage shock and Holter monitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- Male or female
- Age ≥18
- Implanted with any Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Secura®, Virtuoso®, Maximo II®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device to which is attached a St. Jude Riata lead (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042)
- Willing and able to sign informed consent
Who cannot join
- Age <18
- ICD that does not use a Riata lead
- Riata lead not connected to Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Maximo II® Secura®, Virtuoso®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device
- Unwilling or unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Arben Ademi, 860-972-3561, arben.ademi@hhchealth.org
Steven Zweibel, MD
About this study
Official title: Insulation Failure in St. Jude Riata Leads: Screening and Predicting Impending Lead Failure
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.
A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.
Read more
The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.
It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.
Read the detailed description
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.
A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.
The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.
It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.
This will be a prospective, single-center study. Patients who consent to participate will be enrolled for up to three years.
This study offers the potential of direct benefit to the patient and indirect benefit for future users of the ICD systems. This study may identify inside-out insulation breaks and prevent impending lead failure. Additionally, analyses of the data collected as part of this study may help to develop an "electronic footprint" or pattern to remotely identify inside-out insulation breaks in all ICD leads Potential risks include exposure to radiation from a fluoroscopic exam of the lead and receiving a synchronized ICD shock.
- Conditions
- Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device, to Which is Attached a St. Jude Riata Lead
- Being tested
- fluoroscopy, synchronized high-voltage shock, Holter monitor
- Keywords
- St. Jude Riata lead failure, implantable cardioverter-defibrillator (ICD), externalized conductors, ventricular tachyarrythmia, electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoroscopyProcedure or surgery
Fluoroscopic evaluation of three different views (left anterior oblique, right anterior oblique and anterior/posterior) and magnification will be performed to check for externalized cables at 15 frames per second using the best visualized angle per screening electrophysiologist.
synchronized high-voltage shockProcedure or surgery
If fluoroscopic evaluation shows externalized conductors or if patient is deemed high-risk, the patient will be consented for synchronized high voltage shock through his/her device. This will be done in the non-invasive electrophysiology lab with conscious sedation as is done during defibrillation threshold testing.
For patients undergoing a generator (ICD) change as part of standard of care, performance of synchronized, high-voltage shock will be performed at the discretion of the electrophysiologist.
Holter monitorProcedure or surgery
Participants will be given a 24-hour Holter monitor at baseline and once annually, and will be followed at least every three months throughout the study. Participants who are found to have an electrical abnormality at any point during the study may be given a 24-hour Holter monitor if it is believed that this procedure will provide clinically useful information regarding the integrity of the lead.
| Study group | Role | What they receive |
|---|---|---|
| participants | Other | all subjects meeting inclusion and none of exclusion criteria Receives: Procedure: fluoroscopy; Procedure: synchronized high-voltage shock; Procedure: Holter monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
lead failure
clinical and demographic data associated with lead failure will be evaluated after 12-36 months of subject participation
Measured: 12-36 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionApr 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT DeviceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Zweibel, MD, Principal investigator, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095977
- Sponsor's protocol ID
- ZWEI003872
- Status last verified
- Feb 2017
- First submitted
- 28 Jan 2014
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Erkapic D, Duray GZ, Bauernfeind T, De Rosa S, Hohnloser SH. Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol. 2011 Sep;22(9):1018-22. doi: 10.1111/j.1540-8167.2011.02055.x. Epub 2011 Apr 1.
PubMed 21457385Valk S, Luijten R, Jordaens L. Insulation damage in a shock wire: an unexpected fluoroscopic image. Pacing Clin Electrophysiol. 2010 Jun 1;33(6):770-2. doi: 10.1111/j.1540-8159.2009.02664.x. Epub 2010 Jan 12.
PubMed 20070544
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulation Failure in St. Jude Riata Leads: Screening and Predicting Impending Lead Failure
- ClinicalTrials.gov ID
- NCT02095977
- Acronym / sponsor ID
- ZWEI003872
- Conditions
- Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device, to Which is Attached a St. Jude Riata Lead
- Keywords
- St. Jude Riata lead failure, implantable cardioverter-defibrillator (ICD), externalized conductors, ventricular tachyarrythmia, electrophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Mar 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.
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.
A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.
The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.
It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.
Detailed description
A recent study evaluated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices6,9. The FDA updates the database every two months. A total of 107 Riata leads with reported inside-out insulation breaks were found, of which 105 were available for analysis. The average age of the leads was 62.1+/-18.6 months. A total of 226 insulation defects were found with 143 inside-out insulation abrasions. Twenty-eight of the 105 leads (26.7%) had inside-out insulation defects underneath one or more of the high voltage-shocking coil. Of these, 23 were 8F and five were 7F Riata ST leads. Exposed cables or conductors were present in 32 leads and six leads had melted cables, presumably due to one or more high voltage shocks. 22 of the 43 leads assessed (51.2%) also had abraded ETFE cable coating exposing the conductor. Noise and other sensing issues were the most common signs of failure. Seven leads were found to have externalized cables and five exhibited electrical abnormalities. 31 patients (29.5%) experienced inappropriate shocks of which 41% had abraded cables.
A critical decision facing physicians is how to screen and manage patients who are found to have externalized cables. Externalized cables on fluoroscopy may precede any electrical abnormalities. Also noise may not be detected on all ICD models. A recent case report suggested that changes in lead parameters might be transient and may be missed. The lead may function normally as the high-voltage and pace-sense cables are covered with ETFE, which serves as the second insulating barrier. As this is a very thin layer (0.0015 inches) the reliability of this to withstand a high-energy shock is unknown. This may lead to failure of appropriate therapy for life threatening arrhythmias.
The aim of this study is to screen patients with ICD leads that potentially could have multiple different failure mechanisms, including inside-out insulation breaks, to develop a novel new algorithm and methods to detect these defects, thereby enabling physicians to prevent complications from failure of these leads.
It is hypothesized that current monitoring tools are insufficient for detecting the sometimes transient electrical failures of the Riata family of leads, and that additional device diagnostic information in combination with fluoroscopy may improve detection of electrical failures.
This will be a prospective, single-center study. Patients who consent to participate will be enrolled for up to three years.
This study offers the potential of direct benefit to the patient and indirect benefit for future users of the ICD systems. This study may identify inside-out insulation breaks and prevent impending lead failure. Additionally, analyses of the data collected as part of this study may help to develop an "electronic footprint" or pattern to remotely identify inside-out insulation breaks in all ICD leads Potential risks include exposure to radiation from a fluoroscopic exam of the lead and receiving a synchronized ICD shock.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | Other | Procedure: fluoroscopy, Procedure: synchronized high-voltage shock, Procedure: Holter monitorall subjects meeting inclusion and none of exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female
- Age ≥18
- Implanted with any Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Secura®, Virtuoso®, Maximo II®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device to which is attached a St. Jude Riata lead (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042)
- Willing and able to sign informed consent
Key exclusion criteria (4 listed)
- Age <18
- ICD that does not use a Riata lead
- Riata lead not connected to Medtronic Protecta® VR/DR/CRT, XT-VR/DR/CRT, Maximo II® Secura®, Virtuoso®, Concerto® VR, Evera® or Viva® (and any future FDA-approved Medtronic ICD) device
- Unwilling or unable to sign informed consent
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 |
|---|---|---|
| fluoroscopyFluoroscopic evaluation of three different views (left anterior oblique, right anterior oblique and anterior/posterior) and magnification will be performed to check for externalized cables at 15 frames per second using the best visualized angle per screening electrophysiologist. | Procedure or surgery | participants |
| synchronized high-voltage shockIf fluoroscopic evaluation shows externalized conductors or if patient is deemed high-risk, the patient will be consented for synchronized high voltage shock through his/her device. This will be done in the non-invasive electrophysiology lab with conscious sedation as is done during defibrillation threshold testing. For patients undergoing a generator (ICD) change as part of standard of care, performance of synchronized, high-voltage shock will be performed at the discretion of the electrophysiologist. | Procedure or surgery | participants |
| Holter monitorParticipants will be given a 24-hour Holter monitor at baseline and once annually, and will be followed at least every three months throughout the study. Participants who are found to have an electrical abnormality at any point during the study may be given a 24-hour Holter monitor if it is believed that this procedure will provide clinically useful information regarding the integrity of the lead. | Procedure or surgery | participants |
Primary outcome
lead failure
Time frame: 12-36 months post-enrollment
clinical and demographic data associated with lead failure will be evaluated after 12-36 months of subject participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Background: PubMed 21457385Erkapic D, Duray GZ, Bauernfeind T, De Rosa S, Hohnloser SH. Insulation defects of thin high-voltage ICD leads: an underestimated problem? J Cardiovasc Electrophysiol. 2011 Sep;22(9):1018-22. doi: 10.1111/j.1540-8167.2011.02055.x. Epub 2011 Apr 1.
- Background: PubMed 20070544Valk S, Luijten R, Jordaens L. Insulation damage in a shock wire: an unexpected fluoroscopic image. Pacing Clin Electrophysiol. 2010 Jun 1;33(6):770-2. doi: 10.1111/j.1540-8159.2009.02664.x. Epub 2010 Jan 12.
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.
Steven Zweibel, MD principal investigator
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluoroscopy, synchronized high-voltage shock and Holter monitor in people with Implanted With Any Currently (and Any Future) FDA-approved Medtronic ICD or CRT Device and to Which is Attached a St. Jude Riata Lead, run by Hartford Hospital 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 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: status not confirmed, as of the sponsor's last update on 8 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arben Ademi (860-972-3561, arben.ademi@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lead failure (time frame: 12-36 months post-enrollment). 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 NCT02095977, which also lists 2 linked publications.
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 8 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.