The Conformal Prague Study

NCT ID: NCT04193826

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-19
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-valvular AF adults

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.

Group Type: EXPERIMENTAL

Left Atrial Appendage Closure

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or non-pregnant female aged ≥18 years

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

3. High risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2

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

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

6. 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)

Exclusion Criteria

1. 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.

2. 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)

3. 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)

4. 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)

5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated

6. Active infection with bacteremia

7. Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)

8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure

9. Recent (within 90 days of index procedure) stroke, transient ischemic attack

10. Recent myocardial infarction within 60 days of index procedure

11. Vascular access precluding delivery of implant with catheter-based system

12. Severe heart failure (New York Heart Association Class III or IV)

13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant

14. 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

15. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3

16. Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, or device materials (e.g., nickel, titanium, gold), or the patient has contrast sensitivity that cannot be adequately pre-medicated

17. Current participation in another investigational drug or device study that interferes with this study

18. Patient is a prisoner

19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 1 year

20. Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Conformal Medical, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Na Homolce

Prague, , Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 35210077 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-101

Identifier Type: -

Identifier Source: org_study_id