Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-003456
NCT ID: NCT07324031
Sponsor Protocol Number: DOC-10325
About this study
The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System.
The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Exclusion Criteria:
1. Patients who cannot read or write
2. Expected survival \< 1 year
3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
4. Participation in any concurrent clinical study without prior approval from the Sponsor
5. Inability or unwillingness to provide informed consent to participate in the study
6. Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
7. Circumstances that may prevent data collection or completion of specified follow-up visits
8. Allergies to any device materials listed in the Instructions for Use (IFU)
9. Contraindication for temporary suspension of oral/systemic anticoagulation
10. Known history of lung disease with FEV1 \< 1.0 Liter
Device Related:
11. 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, LVAD or neurostimulator
12. Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
13. Any known need for MRI prior to approval of MRI conditional labeling
Anatomy Related:
14. Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
15. Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
16. Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
17. Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
18. History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
19. Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
20. Surgically corrected congenital heart disease (not including catheter-based procedures)
Cardiac Related:
21. Indication for permanent bradycardia pacing or cardiac resynchronization therapy
22. Decompensated heart failure
23. Currently on inotropic therapy
24. Known history of pericardial disease, pericarditis or mediastinitis
25. Risk factors associated with 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 3 months)
* Known inadequate external defibrillation
* LVEF \< 20% (most recent assessment; must be within 180 days of consent)
* LVEDD \>70 mm (most recent assessment; must be within 180 days of consent)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul Friedman, M.D. |
Contact us for the latest status |
|
More information
Publications
Publications are currently not available