The Conformal Prague Study

NCT04193826 | Completed Results FDA Device

• 1 other identifier: 19-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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.

  7 days post-procedure

• Closure Success

  Closure success, defined as device success followed by complete closure or peri-device residual leak ≤5 mm in width

  45-days post-procedure

Study Arms (1)

Non-valvular AF adults

EXPERIMENTAL

Left atrial appendage closure (LAAC) with the Conformal LAAC device will be performed according to the device Instructions for Use, based on 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 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

Non-valvular AF adults

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• 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 a CHA2DS2-VASc score of ≥ 2
• 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 is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations
• The patient (or legally authorized representative) has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate 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 patent 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 of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
• Recent (within 90 days of index procedure) stroke, transient ischemic attack
• Recent myocardial infarction within 60 days of index procedure
• 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 \<100,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3

Sponsors & Collaborators

• Conformal Medical, Inc: lead

Study Sites (1)

Na Homolce

Prague, Czechia

Location

Related Publications (1)

• Turagam MK, Neuzil P, Hala P, Mraz T, Dukkipati SR, Reddy VY. Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes. JACC Clin Electrophysiol. 2022 Feb;8(2):197-207. doi: 10.1016/j.jacep.2021.10.001. Epub 2021 Nov 24.

  PMID: 35210077 DERIVED

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Results Point of Contact

• Title: Aly Dechert / Manager of Clinical Operations
• Organization: Conformal Medical, Inc

adechert@conformalmedical.com

(603) 718-8742

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: October 19, 2019
• Primary Completion: October 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)