Externalized ConductorsCLASNCT01507987
St.Jude Medical Cardiac Lead Assessment Study
An observational study of Externalized Conductors and Visual Lead Anomalies, run by Abbott Medical Devices at 45 sites in 3 countries.
Trial summary
The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Externalized Conductors, Visual Lead Anomalies, Electrical Dysfunction
- What is being tested?
- Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads
- Type of treatment
- Medical device
- How many people
- 2,216 participants
- Where
- 45 sitesin 3 countries
- Study dates
- Mar 2013to Sep 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.
Who may be able to join
- Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
- Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
- Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
- Are 18 years or above
Who cannot join
- Patient is currently pregnant.
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
Trial locations and contacts
45 sites in 3 countries.
45 sites in 3 countries
United States41 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Cardiology, P.C.
Birmingham, Alabama, 35211
University Hospital of Alabama at Birmingham
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Deborah Heart and Lung
Browns Mills, New Jersey, 08015
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Penrose St. Francis Health Services
Colorado Springs, Colorado, 80907
Ohio State University
Columbus, Ohio, 43210
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, 16502
Sutherland Cardiology Clinic
Germantown, Tennessee, 38138
Heart Clinic of Hammond, LLC
Hammond, Louisiana, 70403
Heart Center Research
Huntsville, Alabama, 35801
Jackson Heart Clinic
Jackson, Mississippi, 39216
Mountain States Medical Group Cardiology
Johnson City, Tennessee, 37601
Mid-America Cardiology Associates, PC
Kansas City, Kansas, 66160
Scripps Green Hospital
La Jolla, California, 92037
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Arrhythmia Consultants
Memphis, Tennessee, 38104
Aurora Medical Group
Milwaukee, Wisconsin, 53215
Naples Heart Rhytm Specialists, PA
Naples, Florida, 34119
Ochsner Medical Center
New Orleans, Louisiana, 70121
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Methodist Physicians Clinic-Heart Consultants
Omaha, Nebraska, 68114
OSF Healthcare Cardiovascular Institute
Peoria, Illinois, 61614
Drexel University College oF Medicine
Philadelphia, Pennsylvania, 19102
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Providence Heart & Vascular Institute
Portland, Oregon, 97225
Cardiac Rhythm Specialists
Reseda, California, 91335
Redmond Regional Medical Center
Rome, Georgia, 30165
Mercy Medical Group
Sacramento, California, 95819
University of Utah Hospital
Salt Lake City, Utah, 84132
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
St. Joseph's Medical Center
Stockton, California, 95204
The Toledo Hospital
Toledo, Ohio, 43606
Cardiology Associates of North Mississippi
Tupelo, Mississippi, 38801
Wellspan Health
York, Pennsylvania, 17403
Japan3 sites
Kyoto-Katsura Hospital
Kyoto, 615 8256
Osaka City University Hospital
Osaka, Osaka, 545-8565
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576
About this study
The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).
Read the detailed description
The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.
- Being tested
- Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads
- Keywords
- Externalized Conductors, visual lead an
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leadsDevice
Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010
Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies
| Study group | Role | What they receive |
|---|---|---|
| Patients with SJM leads implanted | Patient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted Receives: Device: Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Leads With Electrical Dysfunction
The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
Measured: This outcome is assessed at enrollment and over the course of 3 years of follow-up
Number of Leads With Externalized Conductors
The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups
Measured: This outcome is assessed at enrollment
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)
The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
Measured: This outcome is assessed at enrollment
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.
Measured: This outcome is assessed from enrollment through the course of 3 years of follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1
Measured: year 1 follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2
Measured: year 1 to year 2 follow-up
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3
Measured: year 2 to year 3 follow-up
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1
Measured: This outcome is assessed from enrollment to year 1
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2
Measured: This outcome is assessed from year 1 to year 2 of follow-up
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3
Measured: This outcome is assessed from year 2 to year 3 follow-up
Secondary outcomes (7)
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant
Kaplan-Meier analysis of time from externalized conductors (EC) to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting EC
Measured: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant
Kaplan-Meier analysis of time from other visual lead anomaly to electrical dysfunction, by year of initial implant. Count of cumulative lead anomaly events from time of detecting other visual lead anomaly
Measured: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other).
Number of participants with adverse events within 30 days associated with study lead related interventions for each lead group
Measured: within 30 days associated with study lead related interventions
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant
time from externalized conductors to clinical intervention for all lead subgroups.
Measured: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant
Kaplan-Meier analysis of time from visual lead anomalies for all lead and lead age subcategories to clinical intervention
Measured: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)
Comparison of patients with EC to those without EC: lead size effect on number of patients with or without EC (7F and 8F are lead sizes, F = French). Riata leads have 8F diameter and Riata ST leads have 7F diameter. The Riata/Riata ST families of leads were used for this comparison only to determine whether the difference in lead size (with the silicon material and other lead design factors controlled for) had an effect on externalization of conductors.
Measured: This outcome is assessed from enrollment till the course of 3 years of follow-up
Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).
Comparison of patients with ED to those without ED: subject age effect on ED
Measured: This outcome is assessed from enrollment till the course of 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMar 2013
- Primary completionJun 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Externalized ConductorsStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- 2,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507987
- Sponsor's protocol ID
- 60039775/K
- Other IDs
- CRD-619
- Acronym
- CLAS
- Status last verified
- Jul 2021
- First submitted
- 6 Jan 2012
- Last updated
- 23 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St.Jude Medical Cardiac Lead Assessment Study
- ClinicalTrials.gov ID
- NCT01507987
- Acronym / sponsor ID
- CLAS / 60039775/K
- Keywords
- Externalized Conductors, visual lead an
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,216 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Posted 23 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).
Detailed description
The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SJM leads implanted | – | Device: Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leadsPatient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.
Key inclusion criteria (4 listed)
- Patient has a market released SJM Implantable Cardioverter Defibrillator (ICD), CRT-D or CRT-P already implanted.
- Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
- Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
- Are 18 years or above
Key exclusion criteria (2 listed)
- Patient is currently pregnant.
- Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
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 |
|---|---|---|
| Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leadsRiata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010 Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies | Device | Patients with SJM leads implanted |
Primary outcome
Number of Leads With Electrical Dysfunction
Time frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up
The prevalence of electrical dysfunction was calculated as the number of leads that have electrical dysfunction through three years of follow-up for the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
Number of Leads With Externalized Conductors
Time frame: This outcome is assessed at enrollment
The prevalence of externalized conductors was calculated as the number of leads that have been shown to have externalized conductors by imaging at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups
Number of Other Visual Lead Anomalies by Each Subcategory (Fracture, Kink, Subclavian Crush, Other Irregularities)
Time frame: This outcome is assessed at enrollment
The prevalence of other visual lead anomalies (by each subcategory) was calculated as the number of leads that have been shown to have other visual anomaly (by each subcategory) at the time of enrollment in each of the 4 lead groups divided by total number of leads in enrolled patients in each of the 4 lead groups.
The Annual Hazard Rate of Lead Electrical Dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time frame: This outcome is assessed from enrollment through the course of 3 years of follow-up
Annual hazard rate is the proportion of number of leads with electrical dysfunction to the total number of lead follow-up years.
The Annual Hazard Rate of New Cases of Externalized Conductors (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time frame: year 1 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from enrollment to year 1
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time frame: year 1 to year 2 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 1 to year 2
The Annual Hazard Rate of New Cases of Externalized Conductors (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads.
Time frame: year 2 to year 3 follow-up
Annual hazard rate calculated as ratio of all leads that are adjudicated by the committee and a have definite outcome of presence of externalized conductors to total follow-up years from year 2 to year 3
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Enrollment to Year 1) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time frame: This outcome is assessed from enrollment to year 1
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from enrollment to year 1
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 1 to Year 2) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time frame: This outcome is assessed from year 1 to year 2 of follow-up
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 1 to year 2
The Annual Hazard Rate of New Cases of Other Visual Lead Anomalies by Each Subcategory (From Year 2 to Year 3) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata Leads
Time frame: This outcome is assessed from year 2 to year 3 follow-up
Annual hazard rate calculated as proportion of leads adjudicated by the committee and a have definite outcome of presence of other visual lead anomaly to total follow up years from year 2 to year 3
7 secondary outcomes
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Electrical Dysfunction, by Year of Initial Implant
Time frame: This outcome is assessed from time of detecting EC till the course of 3 years of follow-up
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Other Visual Lead Anomaly to Electrical Dysfunction, by Year of Initial Implant
Time frame: This outcome is assessed from time of detecting other visual lead anomaly till the course of 3 years of follow-up
Number of Participants With an Adverse Event Through 30 Days Post-intervention for Lead (e.g. Extraction, Abandonment, Revision, Other).
Time frame: within 30 days associated with study lead related interventions
Estimation of Cumulative Lead Anomaly Events From Time of Detecting Externalized Conductors to Clinical Intervention, by Year of Initial Implant
Time frame: This outcome is assessed from time of detection of externalized conductor to 3 years follow-up
Estimation of Lead Anomaly Events From Time of Other Visual Lead Anomalies by Each Subcategory to Clinical Intervention, by Year of Initial Implant
Time frame: This outcome is assessed from time of detection of other visual lead anomaly until 3 years of follow-up
Comparison of Number of Patients With Externalized Conductors to Number of Patients Without Externalized Conductors (EC)
Time frame: This outcome is assessed from enrollment till the course of 3 years of follow-up
Comparison of Patients With Electrical Dysfunction to Those Without Electrical Dysfunction (ED).
Time frame: This outcome is assessed from enrollment till the course of 3 years of follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
45 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Externalized Conductors and Visual Lead Anomalies, run by Abbott Medical Devices at 45 sites in 3 countries.
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 2 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 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Japan, Canada. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Leads With Electrical Dysfunction (time frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up). The study lists 10 primary outcomes in all. 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 23 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.