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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03608670




Registration number
NCT03608670
Ethics application status
Date submitted
12/06/2018
Date registered
1/08/2018

Titles & IDs
Public title
Extravascular ICD Pilot Study
Scientific title
Extravascular ICD Pilot Study
Secondary ID [1] 0 0
MDT17034
Universal Trial Number (UTN)
Trial acronym
EV ICD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia 0 0
Ventricular Arrythmia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Defibrillation using the Extravascular ICD

Experimental: Experimental - Patients will be implanted with an extravascular ICD and undergo requisite electrical testing.


Treatment: Devices: Defibrillation using the Extravascular ICD
VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy Outcome - Number of Participants That Had Successful Termination of Ventricular Fibrillation Episodes at Implantation
Timepoint [1] 0 0
At Implantation
Primary outcome [2] 0 0
Safety Outcome - Percentage of Participants With Freedom From Major System and Procedure Related Complications at 3 Months (90 Days)
Timepoint [2] 0 0
3 months (90 days)

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

[1] Al-Khatib SM, Stevenson WG, Ackerman MJ, Bryant WJ, Callans DJ, Curtis AB, Deal BJ, Dickfeld T, Field ME, Fonarow GC, Gillis AM, Hlatky MA, Granger CB, Hammill SC, Joglar JA, Kay GN, Matlock DD, Myerburg RJ, Page RL. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has indications for bradycardia pacing [1] or Cardiac Resynchronization Therapy (CRT) [2] (Class I, IIa, or IIb indication)
2. Patient has an existing or had a prior pacemaker, ICD, or CRT device implant or leads
3. Patient has anatomical abnormality that significantly increases implant risk[3] including:

• Severe obesity [4]
* Marked RV dilation
* Marked sternal abnormality
* Hiatus hernia that distorts mediastinal anatomy
4. Patient has prior chest radiotherapy
5. Patient had previous mediastinitis
6. Patient had previous coronary artery bypass grafting procedure
7. Patient has existing transcatheter aortic valve replacement
8. Patient has gastrostomy tube
9. Patient has had a prior sternotomy, prior mediastinal instrumentation, prior abdominal surgery in the epigastric region, or planned sternotomy
10. Patient has previous pericarditis that:

• Was chronic and recurrent, or

• Resulted in pericardial effusion [5], or

• Resulted in pericardial thickening or calcification [6]
11. Patients with a medical condition that precludes them from undergoing defibrillation testing, such as:

• known LV thrombus

• decompensated heart failure
* LVEF <20% [7]
* other physician discretion
12. Patient has persistent Atrial Fibrillation who is at high risk of a thromboembolic event with a CHA2DS2-VASc score =3, or is contraindicated for having anticoagulation interrupted for =72 hours
13. Patients with comorbidities which may increase surgical risk of complications[8] including:

• severe aortic stenosis
* COPD and is oxygen dependent
* Hepatosplenomegaly
* Marked hepatomegaly
14. Patient is on renal dialysis
15. Patient with any evidence of active infection or undergoing treatment for an infection
16. Patient with current implantation of neurostimulator or any other chronically implanted device which uses current in the body.
17. Patients with a limited life expectancy of less than 12 months
18. Patient is enrolled or planning to enroll in a concurrent drug or device study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
19. Patient with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding)
20. Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence [9]

[1] 2015 HRS/EHRA/APHRS/SOLAECE expert consensus statement on optimal implantable cardioverter-defibrillator programming and testing).

[2] ACC/AHA/HRS guidelines for Cardiac Resynchronization Therapy [3] Per physician discretion [4] BMI > 40 [5] As documented on echo or MRI [6] As documented on CT scan or MRI [7] Most recent LVEF in the last 180 days (inclusive) [8] Per physician discretion [9] if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to EV ICD Pilot Study procedures

-

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/11/2023
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
MonashHeart - Clayton
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian G Crozier, MB ChB
Address 0 0
Christchurch Hospital, Christchurch, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03608670