ExtraVascular Implantable Cardiac Defibrillator Continued Access Study

NCT05049720 | Withdrawn FDA Device

• 1 other identifier: MDT20054
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Conditions

Tachycardia; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (1)

• Complications

  EV ICD system and/or procedure related adverse events

  Through study completion, an average of 18 months

Study Arms (1)

Experimental

EXPERIMENTAL

Patients will be implanted with an Extravascular ICD and undergo requisite electrical testing.

Device: Defibrillation using the Extravascular ICD

Interventions

Defibrillation using the Extravascular ICD DEVICE

VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

Experimental

Eligibility Criteria

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

You may qualify if:

• Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines.\[1\]
• Patient is willing and able to sign and date the Informed Consent Form for their participation in the study.
• Patient is at least 18 years of age and meets age requirements per local law.
• Patient is geographically stable and willing and able to comply with the study procedures and visits for the duration of the follow-up.

You may not qualify if:

• Patient has indications for bradycardia pacing\[2\] or Cardiac Resynchronization Therapy (CRT)\[3\] (Class I, IIa, or IIb indication).
• Patients with an existing pacemaker, ICD, or CRT device or leads.
• Patients with these medical interventions are excluded from participation in the study:
• Prior sternotomy
• Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis)
• Prior abdominal surgery in the epigastric region
• Planned sternotomy
• Prior chest radiotherapy
• Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
• Patients with these medical conditions or anatomies are excluded from participation in the study:
• Hiatal hernia that distorts mediastinal anatomy
• Marked sternal abnormality (e.g., pectus excavatum that impedes the substernal tunneling path or procedure)
• Decompensated heart failure
• COPD with oxygen dependence
• Gross hepatosplenomegaly

Sponsors & Collaborators

• Medtronic: lead

Related Publications (3)

• Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Granger CB, Hammill SC, Hlatky MA, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2018 Oct 2;72(14):e91-e220. doi: 10.1016/j.jacc.2017.10.054. Epub 2018 Aug 16. No abstract available.

  PMID: 29097296 BACKGROUND

• Wilkoff BL, Fauchier L, Stiles MK, Morillo CA, Al-Khatib SM, Almendral J, Aguinaga L, Berger RD, Cuesta A, Daubert JP, Dubner S, Ellenbogen KA, Mark Estes NA 3rd, Fenelon G, Garcia FC, Gasparini M, Haines DE, Healey JS, Hurtwitz JL, Keegan R, Kolb C, Kuck KH, Marinskis G, Martinelli M, McGuire M, Molina LG, Okumura K, Proclemer A, Russo AM, Singh JP, Swerdlow CD, Teo WS, Uribe W, Viskin S, Wang CC, Zhang S. 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing. Heart Rhythm. 2016 Feb;13(2):e50-86. doi: 10.1016/j.hrthm.2015.11.018. Epub 2015 Dec 1. No abstract available.

  PMID: 26607062 BACKGROUND

• Kusumoto FM, Schoenfeld MH, Barrett C, Edgerton JR, Ellenbogen KA, Gold MR, Goldschlager NF, Hamilton RM, Joglar JA, Kim RJ, Lee R, Marine JE, McLeod CJ, Oken KR, Patton KK, Pellegrini CN, Selzman KA, Thompson A, Varosy PD. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Aug 20;74(7):e51-e156. doi: 10.1016/j.jacc.2018.10.044. Epub 2018 Nov 6. No abstract available.

  PMID: 30412709 BACKGROUND

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 20, 2021
• Study Start: September 1, 2022
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share