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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06592001




Registration number
NCT06592001
Ethics application status
Date submitted
9/09/2024
Date registered
19/09/2024
Date last updated
15/10/2024

Titles & IDs
Public title
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
Scientific title
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
Secondary ID [1] 0 0
DOC-10280
Universal Trial Number (UTN)
Trial acronym
ASCEND EV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Arrythmia 0 0
Ventricular Fibrillation 0 0
Ventricular Tachycardia 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 - Atala™ lead

Experimental: AtaCor EV-ICD Lead System - Subjects implanted with the Atala™ lead


Treatment: Devices: Atala™ lead
Subjects will receive the Atala™ lead being evaluated in the study.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from major ADEs
Timepoint [1] 0 0
Through 3 months post-implant
Primary outcome [2] 0 0
Successful IVA Test
Timepoint [2] 0 0
At the time of procedure

Eligibility
Key inclusion criteria
1. At least 18 years old
2. Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participation in any concurrent clinical study without prior written approval from the Sponsor
2. Inability or unwillingness to provide informed consent to participate in the Study
3. Any known conditions which may complicate the AtaCor EV-ICD Lead System implant procedure or prevent the subject from completing protocol testing through the 3-month follow-up visit
4. Circumstances that may prevent data collection or completion of specified follow-up visits
5. Allergies to any device materials listed in the Instructions for Use (IFU)
6. Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
7. Known history of lung disease with FEV1 < 1.0 Liter

Device Related:
8. Presence or planned use of medical devices that introduce current into the body (e.g., pacemaker, LVAD, neurostimulator, etc.)
9. Implanted with or planned implantation of any device which delivers current in the body, that may interfere with therapy delivery, including, but not limited to a pacemaker, or neurostimulator
10. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
11. Any known need for future MRI

Anatomy Related:
12. BMI = 35 kg/m2
13. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
14. Prior sternotomy of any type, including but not limited to median, mini or clamshell
15. Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
16. Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) and associated with displacement of the heart or lungs or impeded mediastinal access.
17. History of thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
18. Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
19. Surgically corrected congenital heart disease (not including catheter-based procedures)

Cardiac Related:
20. Subjects who require permanent bradycardia pacing or cardiac resynchronization therapy
21. NYHA IV functional class in past 90 days
22. Inotropic therapy in past 180 days
23. Known history of pericardial disease, pericarditis or mediastinitis
24. Patients with a medical condition that precludes them from undergoing defibrillation testing:

* Severe aortic stenosis
* Current Intracardiac LA or LV thrombus
* Severe proximal three-vessel or left main coronary artery disease without revascularization
* Hemodynamic instability
* Unstable angina
* Recent stroke or transient ischemic attack (within the last 6 months)
* Known inadequate external defibrillation
* LVEF < 20%
* LVEDD >70 mm

Study design
Purpose of the study
Treatment
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
25/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Croatia
State/province [1] 0 0
Split
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
Paraguay
State/province [3] 0 0
Asunción

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AtaCor Medical, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Hase, BS, CCRA
Address 0 0
Country 0 0
Phone 0 0
+1 949-545-9820
Fax 0 0
Email 0 0
sarah@atacor.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06592001