Conscious Sedation Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: CLAAS® System
- Registration Number
- NCT06049615
- Lead Sponsor
- Conformal Medical, Inc
- Brief Summary
The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.
- Detailed Description
The Sub-Study is a prospective single arm trial evaluating a conscious sedation protocol. The Sub-Study will evaluate the safety and performance of the CLAAS device using conscious sedation in comparison with the device delivery safety and performance observed in the CLAAS arm of the RCT. The Sub-Study will be performed in accordance with all protocol requirements and all subjects will be evaluated for Primary Endpoint based on the product performance at the 45 days post procedure assessment. Enrollment in the Sub-Study will not commence until enrollment in the randomized cohort is complete, initial safety of the CLAAS system is confirmed by the DSMB and FDA approval of the Sub-Study has been granted through an IDE Supplement. All subjects enrolled in the conscious sedation single arm study will follow the same clinical protocol requirements and follow-up as the randomized subjects. The Sub-Study will be identified by an NCT that is separate from the RCT with Roll-in.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CLAAS CLAAS® System Subjects to be implanted with the CLAAS device.
- Primary Outcome Measures
Name Time Method Primary Efficacy: Evaluating the Performance of CLAAS, as defined below: 7 days through 45 days post-procedure 1. Successful implantation of the LAAO Device in the LAA with acceptable position (e.g. as measured at LAA orifice) through 45 days post-procedure
2. Complete closure or peri-device residual leak ≤5 mm in width on TEE, as evaluated by independent core lab at 45 days post-procedure
3. Without in-hospital major procedure-related complications during hospitalization or at 7 days, whichever is firstPrimary Safety: A Composite of Major Procedure-Related Complications Assessed through 45-Days 45 days post procedure A composite of Major Procedure-related complications assessed through 45 days (listed below) as adjudicated by an independent Clinical Events Committee as related to either the study device or procedure.
Major Procedure-Related Complications includes any of the following specific events with the specific definitions outlined for each component:
* cardiac perforation,
* pericardial effusion requiring drainage,
* ischemic stroke,
* device embolization,
* major vascular complications
- Secondary Outcome Measures
Name Time Method