Avoid Transvenous Leads in Appropriate Subjects

NCT02881255 | Completed DMC FDA Device

• 1 other identifier: ATLAS S-ICD
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Ventricular Arrhythmia

Keywords

implantable cardioverter defibrillator; subcutaneous ICD; transvenous ICD; inherited arrhythmia syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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;

  6 months post-ICD implantation

Secondary Outcomes (9)

• Late device-related complications

  Greater than 6 months post-ICD implantation

• Total device-related complications

  Greater than 6 months post-ICD implantation

• Occurrence of failed appropriate shock or arrhythmic death

  6 months post-ICD implantation

• Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure

  6 months post-ICD implantation

• Any inappropriate ICD therapy shock

  6 months post-ICD implantation

Study Arms (2)

Subcutaneous ICD

OTHER

Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)

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.

Device: Implantable Cardioverter Defibrillator

Interventions

Implantable Cardioverter Defibrillator DEVICE

Patients will be randomized to receive either a subcutaneous or transvenous ICD.

Subcutaneous ICD; Transvenous ICD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is ≥ 18 - 60 years old AND has a standard indication for ICD; OR
• Patient is ≥ 18 years old AND has any one of the following present:
• An inherited arrhythmia syndrome (i.e. Long QT, Brugada, ARVC, hypertrophic or dilated cardiomyopathy, early repolarization syndrome, idiopathic ventricular fibrillation, etc.)
• Prior pacemaker or ICD removal for infection
• Need for hemodialysis
• Prior heart valve surgery (repair or replacement)
• Chronic obstructive pulmonary disease (with FEV1 \< 1.5 L)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Population Health Research Institute: lead
• Boston Scientific Corporation: collaborator

Study Sites (14)

University of Calgary

Calgary, Alberta, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Victoria Cardiac Arrhythmia Trials Inc.

Victoria, British Columbia, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Location

IUCPQ-Universite Laval

Laval, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

Location

Related Publications (3)

• 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.

  PMID: 30399474 BACKGROUND

• Carroll 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.

  PMID: 38695087 DERIVED

• Healey 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.

  PMID: 36343346 DERIVED

MeSH Terms

Interventions

Defibrillators, Implantable

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Jeff Healey, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

• Blandine Mondesert, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 26, 2016
• Study Start: February 22, 2017
• Primary Completion: January 31, 2022
• Study Completion: February 10, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)