ACTIVE_NOT_RECRUITING

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Conditions

Aortic Valve Stenosis Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Replacement

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Study Overview

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Description

The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems. This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.

Official Title

A Prospective, Randomized, Multicenter Evaluation of the Safety and Effectiveness of the EMBLOK Embolic Protection System During Transcatheter Aortic Valve Replacement

Quick Facts

Study Start:2023-10-17

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05295628

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is between 18 and 90 years of age. 2. Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve. 3. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure. 4. Subject agrees to comply with all protocol-specified procedures and assessments. 5. Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation.	1. Subjects with a previously implanted aortic or mitral valve bioprosthesis 2. Subjects with hepatic failure (Child-Pugh class C). 3. Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin. 4. Subjects who have a planned treatment with any other investigational device or procedure during the study period. 5. Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure. 6. Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure. 7. Subject requires an urgent or emergent TAVR procedure. 8. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula). 9. Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit. 10. Subject has an ejection fraction of 30% or less. 11. Subject has a sensitivity to contrast media that cannot be adequately pre-treated. 12. Subject has known allergy or hypersensitivity to any embolic protection device materials (e.g., nickel-titanium) or allergy to intravascular contrast agents that cannot be pre-medicated 13. Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \> 38°C and/ or white blood cell \> 15,000 IU. 14. Subjects undergoing therapeutic thrombolysis. 15. Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy. 16. Subject is known or suspected to be pregnant, or is lactating. 17. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.

Inclusion Criteria

Exclusion Criteria

1. Subject is between 18 and 90 years of age.
2. Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve.
3. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
4. Subject agrees to comply with all protocol-specified procedures and assessments.
5. Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation.

1. Subjects with a previously implanted aortic or mitral valve bioprosthesis
2. Subjects with hepatic failure (Child-Pugh class C).
3. Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
4. Subjects who have a planned treatment with any other investigational device or procedure during the study period.
5. Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.
6. Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure.
7. Subject requires an urgent or emergent TAVR procedure.
8. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula).
9. Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit.
10. Subject has an ejection fraction of 30% or less.
11. Subject has a sensitivity to contrast media that cannot be adequately pre-treated.
12. Subject has known allergy or hypersensitivity to any embolic protection device materials (e.g., nickel-titanium) or allergy to intravascular contrast agents that cannot be pre-medicated
13. Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \> 38°C and/ or white blood cell \> 15,000 IU.
14. Subjects undergoing therapeutic thrombolysis.
15. Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy.
16. Subject is known or suspected to be pregnant, or is lactating.
17. Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.

Contacts and Locations

Principal Investigator

Hemal Gada, MD

PRINCIPAL_INVESTIGATOR

Heart and Vascular Institute, UPMC Pinnacle

Study Locations (Sites)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, 85224

United States

St Joseph's Providence

Orange, California, 92868

United States

Sutter Medical Center Sacramento

Sacramento, California, 95816

United States

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105

United States

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360

United States

Hartford Hospital

Hartford, Connecticut, 06106

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

United States

Ascension Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, 67226

United States

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Corewell Health

Grand Rapids, Michigan, 49503

United States

University of Washington School of Medicine Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112

United States

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17101

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19091

United States

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research

Plano, Texas, 75093

United States

Methodist Hospital

San Antonio, Texas, 78229

United States

Sentra Norfolk General Hospital

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Innovative Cardiovascular Solutions

Hemal Gada, MD, PRINCIPAL_INVESTIGATOR, Heart and Vascular Institute, UPMC Pinnacle

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-17

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2023-10-17

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Aortic Valve Stenosis
Aortic Valve Disease
Aortic Valve Insufficiency
Aortic Valve Replacement