NCT04193826

The Conformal Prague Study

The Conformal Prague Study: An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Conformal Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.

Detailed description

The primary objective of the study is to evaluate feasibility of ICE as primary imaging modality for device success in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism who are recommended for oral anticoagulation (OAC) therapy but have an appropriate rationale to seek a non-pharmacological alternative to OAC. TEE will be used to confirm the ICE evaluation.

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Left Atrial Appendage Closure	Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing

Timeline

• Start date: 2019-10-19
• Primary completion: 2022-10-30
• Completion: 2022-12-31
• First posted: 2019-12-10
• Last updated: 2024-09-24
• Results posted: 2024-09-24

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study