Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study (NCT06592001) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
Croatia, New Zealand, Paraguay19 participantsStarted 2025-02-25
Plain-language summary
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of follow-up to inform the design of a subsequent pivotal clinical investigation.
The objectives of the study are to: 1) preliminarily validate safety and effectiveness of the Atalaâ„¢ lead as a permanent ICD lead when used with a compatible ICD pulse generator, 2) evaluate suitability of clinical study testing methods and 3) inform statistically powered primary safety and effectiveness endpoints in a subsequent pivotal clinical investigation.
Who can participate
Age range18 Years
SexALL
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Inclusion 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
Exclusion criteria
✕. Participation in any concurrent clinical study without prior written approval from the Sponsor
✕. Inability or unwillingness to provide informed consent to participate in the Study
✕. 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
✕. 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)
✕. Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
✕. Known history of lung disease with FEV1 \< 1.0 Liter