The CONFORMAL Early Feasibility Study

NCT03616028 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 18-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Freedom from major adverse events:

  Major adverse events defined as: All cause mortality, ischemic stroke, systemic thromboembolism, device or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention.

  up to 45 days

Secondary Outcomes (2)

• Closure success

  45 days post procedure, 6 months, 12 months

• Major Adverse Events

  1year, 2 years, 3 years, 4 years, 5 years

Study Arms (1)

Non-valvular AF adults

EXPERIMENTAL

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.

Device: left atrial appendage closure

Interventions

left atrial appendage closure DEVICE

Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS 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

Non-valvular AF adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patient foramen ovale \[PFO\] surgical repair or implanted closure device, or obliterated or ligated left atrial appendage)
• Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
• Patients with a medical condition (other than atrial fibrillation) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
• History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
• Active infection with bacteremia
• Documented symptomatic carotid artery disease (\>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of \>70%)
• Recent (within 30 days pre-procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
• Recent (within 90 days pre-procedure) stroke or transient ischemic attack.
• Recent (within 60 days pre-procedure) myocardial infarction
• Vascular access precluding delivery of implant with catheter-based system
• Severe heart failure (New York Heart Association Class III or IV)
• Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening
• Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3

Sponsors & Collaborators

• Conformal Medical, Inc: lead
• Yale Cardiovascular Research Group: collaborator

Study Sites (11)

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Lankenau Heart Institute

Wynnewood, Pennsylvania, 19096, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78705, United States

Location

Baylor Scott & white Research Institute

Plano, Texas, 75093, United States

Location

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• William A Gray, MD

  Main Line Health Lankenau Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, open-label, first-in-human study aimed at examining the performance of the CLAAS device for LAA closure.

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 6, 2018
• Study Start: February 22, 2019
• Primary Completion: May 27, 2022
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)