The CONFORMAL Early Feasibility Study An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Status: Active_not_recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Male or non-pregnant female aged ≥18 years

• Documented non-valvular AF (paroxysmal, persistent, or permanent)

• High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women

• The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation

• The patient deemed appropriate for LAA closure by the Site P.I. and a non-interventional physician using an evidenced-based decision-making tool on oral anticoagulants consistent with standard of care.

• The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations

• The patient (or legally authorized representative, (where allowed)) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Locations
United States
Arkansas
St. Bernards Medical Center
Jonesboro
California
Pacific Heart Institute
Santa Monica
New Hampshire
Catholic Medical Center
Manchester
New York
Columbia University Medical Center/NYPH
New York
Mount Sinai
New York
Ohio
The Christ Hospital
Cincinnati
Pennsylvania
Lankenau Heart Institute
Wynnewood
Tennessee
Erlanger Health System
Chattanooga
Vanderbilt University Medical Center
Nashville
Texas
Texas Cardiac Arrhythmia Institute
Austin
Baylor Scott & white Research Institute
Plano
Time Frame
Start Date: 2019-02-22
Completion Date: 2025-06
Participants
Target number of participants: 64
Treatments
Experimental: Non-valvular AF adults
Left atrial appendage closure (LAAC) with the CLAAS device will be performed according to the device Instructions for Use, based on TEE, ICE and angiographic guidance, femoral venous access and inter-atrial septum crossing.
Related Therapeutic Areas
Sponsors
Collaborators: Yale Cardiovascular Research Group
Leads: Conformal Medical, Inc

This content was sourced from clinicaltrials.gov