Ventricular ArrhythmiaATLAS S-ICDNCT02881255
Avoid Transvenous Leads in Appropriate Subjects
A study testing Implantable Cardioverter Defibrillator in people with Ventricular Arrhythmia, run by Population Health Research Institute at 14 sites in Canada.
Trial summary
The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmia
- What is being tested?
- Implantable Cardioverter Defibrillator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 14 sitesCanada
- Study dates
- 22 Feb 2017to 10 Feb 2022
- 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
None listed.
Who cannot join
- Mechanical tricuspid valve
- Fontan repair
- Presence of an intra-cardiac shunt
- Known lack of upper extremity venous access
- Need for cardiac pacing for bradycardia indication
- PR interval of > 240 msec
Show all 11Show fewer
- Patients with permanent pacemaker
- Clinical indication for biventricular pacing
- Patients unwilling to provide informed consent or comply with follow-up
- Pregnant at time of enrollment and implant
- Patients who currently have a ventricular assist device (i.e. LVAD)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
University of Calgary
Calgary, Alberta
Mazankowski Alberta Heart Institute
Edmonton, Alberta
Hamilton General Hospital
Hamilton, Ontario
IUCPQ-Universite Laval
Laval, Quebec
McGill University Health Centre
Montreal, Quebec
Montreal Heart Institute
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia
About this study
The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.
- Conditions
- Ventricular Arrhythmia
- Being tested
- Implantable Cardioverter Defibrillator
- Keywords
- implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter DefibrillatorDevice
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous ICD | Other | Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM) Receives: Device: Implantable Cardioverter Defibrillator |
| Transvenous ICD | Other | Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring. Receives: Device: Implantable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of lead-related perioperative complications
This composite includes:
Hemothorax or pneumothorax; Cardiac perforation, tamponade, pericardial effusion or pericarditis; Lead dislodgement or loss of pacing/sensing requiring revision; New moderate-severe or severe tricuspid insufficiency (3+ or 4+); Ipsilateral upper extremity deep venous thrombosis.
Measured: 6 months post-ICD implantation
Additional safety composite
This composite includes:
Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death;
Measured: 6 months post-ICD implantation
Secondary outcomes (9)
Late device-related complications
The following complications will be measured by their presence or absence; they will be presented as individual complications and also as a composite of late device-related complications:
- Lead dislodgement or fracture; or loss of adequate sensing or pacing
- Device-related infection
- Pericarditis or pericardial effusion
- New severe tricuspid insufficiency
- Ipsilateral upper extremity deep venous thrombosis
- Need to revise dialysis access
- Need to revise ICD or lead for any reason
- Non-systemic embolism
- Pulmonary embolism
- Wound dehiscence or disjunction
- Allergic reaction to ICD
Measured: Greater than 6 months post-ICD implantation
Total device-related complications
This is a composite of:
all components of the primary and secondary safety outcomes, and late device-related complications.
Measured: Greater than 6 months post-ICD implantation
Occurrence of failed appropriate shock or arrhythmic death
Efficacy outcome
Measured: 6 months post-ICD implantation
Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure
Efficacy outcome. Hospital, emergency department or clinic visits for ICD therapy (shocks or anti-tachycardia pacing, both appropriate and inappropriate), device-related complications, arrhythmia or heart failure
Measured: 6 months post-ICD implantation
Any inappropriate ICD therapy shock
Efficacy outcome
Measured: 6 months post-ICD implantation
All-cause mortality
Efficacy outcome
Measured: 6 months post-ICD implantation
Provincial healthcare payer health economics analysis
A formal health economics analysis will be completed as part of this study, using the perspective of a provincial healthcare payer. Procedural costs will be obtained from the Ontario schedule of benefits and the cost of device-implantation will be taken from existing, local case-costing data. The cost-effectiveness analysis will take into consideration any differences in survival, complication rates and resource utilization. Sensitivity analyses will be done, varying the price of the S-ICD, in order to generate cost-acceptability curves.
Measured: 6 months post-ICD implantation
Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)
Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS).
Measured: 1 month and 6 month post-ICD implantation
Patient Health Survey as measured by Short Form Health Survey (SF36)
Patient health will be assessed by a generic instrument, the Short Form Health Survey (SF36). This survey provides scores for each of the eight health domains and psychometrically-based physical component summary and mental component summary scores.
Measured: Baseline and 6 months post-ICD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start22 Feb 2017
- Primary completion31 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventricular ArrhythmiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Jeff Healey, MD, Principal investigator, Population Health Research InstituteBlandine Mondesert, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881255
- Sponsor's protocol ID
- ATLAS S-ICD
- Acronym
- ATLAS S-ICD
- Status last verified
- May 2022
- First submitted
- 2 Aug 2016
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mondesert B, Bashir J, Philippon F, Dubuc M, Amit G, Exner D, Joza J, Birnie DH, Lane C, Tsang B, Korley V, Spears D, Ling A, Djuric A, Crystal E, Hruczkowski T, Roux JF, Carroll S, Essebag V, Krahn AD, Healey JS. Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects. Am Heart J. 2019 Jan;207:1-9. doi: 10.1016/j.ahj.2018.09.008. Epub 2018 Oct 9.
PubMed 30399474Carroll SL, Mondesert B, Krahn AD, Bashir JG, Fisher K, Nair K, Healey JS. Device-specific quality of life: results from the ATLAS trial-avoid transvenous leads in appropriate subjects. Eur J Cardiovasc Nurs. 2024 Dec 16;23(8):877-885. doi: 10.1093/eurjcn/zvae067.
PubMed 38695087Healey JS, Krahn AD, Bashir J, Amit G, Philippon F, McIntyre WF, Tsang B, Joza J, Exner DV, Birnie DH, Sadek M, Leong DP, Sikkel M, Korley V, Sapp JL, Roux JF, Lee SF, Wong G, Djuric A, Spears D, Carroll S, Crystal E, Hruczkowski T, Connolly SJ, Mondesert B; ATLAS Investigators. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial. Ann Intern Med. 2022 Dec;175(12):1658-1665. doi: 10.7326/M22-1566. Epub 2022 Nov 8.
PubMed 36343346
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoid Transvenous Leads in Appropriate Subjects
- ClinicalTrials.gov ID
- NCT02881255
- Acronym / sponsor ID
- ATLAS S-ICD / ATLAS S-ICD
- Conditions
- Ventricular Arrhythmia
- Keywords
- implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 26 Aug 2016 (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 the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous ICD | Other | Device: Implantable Cardioverter DefibrillatorPatient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM) |
| Transvenous ICD | Other | Device: Implantable Cardioverter DefibrillatorPatient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Mechanical tricuspid valve
- Fontan repair
- Presence of an intra-cardiac shunt
- Known lack of upper extremity venous access
- Need for cardiac pacing for bradycardia indication
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 |
|---|---|---|
| Implantable Cardioverter DefibrillatorPatients will be randomized to receive either a subcutaneous or transvenous ICD. | Device | Subcutaneous ICD, Transvenous ICD |
Primary outcome
Composite of lead-related perioperative complications
Time frame: 6 months post-ICD implantation
This composite includes: Hemothorax or pneumothorax; Cardiac perforation, tamponade, pericardial effusion or pericarditis; Lead dislodgement or loss of pacing/sensing requiring revision; New moderate-severe or severe tricuspid insufficiency (3+ or 4+); Ipsilateral upper extremity deep venous thrombosis.
Additional safety composite
Time frame: 6 months post-ICD implantation
This composite includes: Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death;
9 secondary outcomes
Late device-related complications
Time frame: Greater than 6 months post-ICD implantation
Total device-related complications
Time frame: Greater than 6 months post-ICD implantation
Occurrence of failed appropriate shock or arrhythmic death
Time frame: 6 months post-ICD implantation
Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure
Time frame: 6 months post-ICD implantation
Any inappropriate ICD therapy shock
Time frame: 6 months post-ICD implantation
All-cause mortality
Time frame: 6 months post-ICD implantation
Provincial healthcare payer health economics analysis
Time frame: 6 months post-ICD implantation
Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)
Time frame: 1 month and 6 month post-ICD implantation
Patient Health Survey as measured by Short Form Health Survey (SF36)
Time frame: Baseline and 6 months post-ICD implantation
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 31 May 2022.
- Background: PubMed 30399474Mondesert B, Bashir J, Philippon F, Dubuc M, Amit G, Exner D, Joza J, Birnie DH, Lane C, Tsang B, Korley V, Spears D, Ling A, Djuric A, Crystal E, Hruczkowski T, Roux JF, Carroll S, Essebag V, Krahn AD, Healey JS. Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects. Am Heart J. 2019 Jan;207:1-9. doi: 10.1016/j.ahj.2018.09.008. Epub 2018 Oct 9.
- Derived from this study: PubMed 38695087Carroll SL, Mondesert B, Krahn AD, Bashir JG, Fisher K, Nair K, Healey JS. Device-specific quality of life: results from the ATLAS trial-avoid transvenous leads in appropriate subjects. Eur J Cardiovasc Nurs. 2024 Dec 16;23(8):877-885. doi: 10.1093/eurjcn/zvae067.
- Derived from this study: PubMed 36343346Healey JS, Krahn AD, Bashir J, Amit G, Philippon F, McIntyre WF, Tsang B, Joza J, Exner DV, Birnie DH, Sadek M, Leong DP, Sikkel M, Korley V, Sapp JL, Roux JF, Lee SF, Wong G, Djuric A, Spears D, Carroll S, Crystal E, Hruczkowski T, Connolly SJ, Mondesert B; ATLAS Investigators. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial. Ann Intern Med. 2022 Dec;175(12):1658-1665. doi: 10.7326/M22-1566. Epub 2022 Nov 8.
- Individual participant dataSharing planned: No
Related trials for Ventricular Arrhythmia
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Not yet recruiting
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Cardiotoxicity, Cancer
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
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.
Jeff Healey, MD principal investigator
Population Health Research Institute
Blandine Mondesert, MD principal investigator
Université de Montréal
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator in people with Ventricular Arrhythmia, run by Population Health Research Institute at 14 sites in Canada.
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 0 inclusion and 11 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in 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?
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?
Composite of lead-related perioperative complications (time frame: 6 months post-ICD implantation). The study lists 2 primary outcomes in all. 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 NCT02881255, which also lists 3 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 31 May 2022.