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New treatment option for Ventricular Arrythmia
Official title Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
ClinicalTrials.gov ID: NCT07324031
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years old
- Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
You likely can't join if
- Patients who cannot read or write
- Expected survival \< 1 year
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period
- Participation in any concurrent clinical study without prior approval from the Sponsor
- Inability or unwillingness to provide informed consent to participate in the study
- Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
See the full eligibility criteria
- At least 18 years old
- Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
- Patients who cannot read or write
- Expected survival \< 1 year
- Pregnant or nursing people and those who plan pregnancy during the clinical investigation follow-up period
- Participation in any concurrent clinical study without prior approval from the Sponsor
- Inability or unwillingness to provide informed consent to participate in the study
- Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
- Circumstances that may prevent data collection or completion of specified follow-up visits
- Allergies to any device materials listed in the Instructions for Use (IFU)
- Contraindication for temporary suspension of oral/systemic anticoagulation
- Known history of lung disease with FEV1 \< 1.0 Liter Device Related:
- 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
- Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
- Any known need for MRI prior to approval of MRI conditional labeling Anatomy Related:
- Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
- Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
- Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
- Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
- History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
- Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
- Surgically corrected congenital heart disease (not including catheter-based procedures) Cardiac Related:
- Indication for permanent bradycardia pacing or cardiac resynchronization therapy
- Decompensated heart failure
- Currently on inotropic therapy
- Known history of pericardial disease, pericarditis or mediastinitis
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jonesboro, Arkansas, United States
- La Jolla, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Washington D.C., District of Columbia, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Glenview, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Voorhees Township, New Jersey, United States
- Manhasset, New York, United States
- Charlotte, North Carolina, United States
- Greenville, North Carolina, United States
- Raleigh, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
+ 14 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jonesboro, Arkansas, United States; La Jolla, California, United States; Orange, California, United States; Santa Monica, California, United States; Washington D.C., District of Columbia, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.