The Sentara Heart Valve and Structural Disease Center
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 12 Trials 
23 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Mahoney, Paul D
PORTICO IDE, NCT02000115: Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Recruiting
N/A
1150
US, RoW
Portico transcatheter aortic valve, Commercially available transcatheter aortic valve
Abbott Medical Devices
Aortic Valve Stenosis
10/19
07/25
NCT03904147: TRILUMINATE Pivotal Trial

Active, not recruiting
N/A
572
Europe, Canada, US
TriClipTM Device
Abbott Medical Devices
Tricuspid Regurgitation
11/22
04/29
CLASP IID, NCT03706833: Edwards PASCAL /IIF Pivotal Clinical Trial

Recruiting
N/A
1247
Europe, Canada, US
Edwards PASCAL System, Transcatheter Mitral Valve repair (TMVr), Abbott Mitraclip System
Edwards Lifesciences
Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
01/25
04/30
NCT03735667: ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement

Active, not recruiting
N/A
1948
Canada, US
ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System, ACURATE Prime™ Transfemoral TAVR System XL
Boston Scientific Corporation
Aortic Stenosis
06/24
09/34
NCT04482062: TRISCEND II Pivotal Trial

Active, not recruiting
N/A
1070
Europe, US
Edwards EVOQUE System, Transcatheter tricuspid valve replacement, Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
06/24
12/29
MITRAL-II, NCT04408430: The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Recruiting
N/A
210
US
Transseptal ViMAC, ViMAC
Mayra Guerrero
Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
12/24
12/24
NCT05295628: Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

Recruiting
N/A
532
US
EMBLOK™ Embolic Protection System ("EMBLOK EPS"), SENTINEL™ Cerebral Protection System
Innovative Cardiovascular Solutions, Yale Cardiovascular Research Group
Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Valve Replacement
01/25
02/25
NCT04198870: MitraClip REPAIR MR Study

Recruiting
N/A
500
Europe, Canada, US
MitraClip™ device implantation, Mitral Valve Repair Surgery
Abbott Medical Devices
Mitral Valve Regurgitation
04/26
04/34
APOLLO, NCT03242642: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Recruiting
N/A
1056
Europe, Canada, US
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Cardiovascular
Mitral Valve Regurgitation
10/26
09/36
REDUCE PAS, NCT03821129: GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study

Recruiting
N/A
636
US
PFO closure with GORE® CARDIOFORM Septal Occluder
W.L.Gore & Associates
Stroke, PFO - Patent Foramen Ovale
12/26
12/29
NCT03142152: The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Recruiting
N/A
300
Europe, US
Carillon Mitral Contour System, Carillon, Percutaneous mitral valve repair, Guideline Directed Heart Failure Medication
Cardiac Dimensions, Inc.
Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases
12/26
12/30
ENVISION, NCT05932615: IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

Enrolling by invitation
N/A
1500
Canada, US
Navitor Transcatheter Aortic Valve Implantation (TAVI) System, Any Commercially Available Transcatheter Aortic Valve (CAV) System
Abbott Medical Devices
Aortic Valve Stenosis, Heart Valve Diseases, Aortic Valve Disease, Heart Disease Structural Disorder
04/27
04/36
Muhammad, Kamran
CLASP IID, NCT03706833: Edwards PASCAL /IIF Pivotal Clinical Trial

Recruiting
N/A
1247
Europe, Canada, US
Edwards PASCAL System, Transcatheter Mitral Valve repair (TMVr), Abbott Mitraclip System
Edwards Lifesciences
Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
01/25
04/30
SUMMIT, NCT03433274: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Recruiting
N/A
958
Canada, US
Tendyne Mitral Valve System, MitraClip System
Abbott Medical Devices
Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease, Heart, Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease
05/24
06/28
CorCinch-HF, NCT04331769: Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): the CORCINCH-HF Study

Recruiting
N/A
400
Europe, US, RoW
AccuCinch Ventricular Restoration System, Guideline-Directed Medical Therapy
Ancora Heart, Inc.
Heart Failure with Reduced Ejection Fraction (HFrEF), Dilated Cardiomyopathy
12/26
12/30
NCT04482062: TRISCEND II Pivotal Trial

Active, not recruiting
N/A
1070
Europe, US
Edwards EVOQUE System, Transcatheter tricuspid valve replacement, Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
06/24
12/29
ALT-FLOW II, NCT05686317: Trial of the Edwards APTURE Transcatheter Shunt System

Recruiting
N/A
100
Europe, Canada, US
Edwards APTURE transcatheter shunt system, Sham procedure
Edwards Lifesciences
Heart Failure
01/26
07/30
MITRAL-II, NCT04408430: The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Recruiting
N/A
210
US
Transseptal ViMAC, ViMAC
Mayra Guerrero
Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
12/24
12/24
CLASP II TR, NCT04097145: Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Recruiting
N/A
870
Canada, US
Edwards PASCAL System, Transcatheter tricuspid valve repair (TTVr), Optimal Medical Therapy
Edwards Lifesciences
Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
12/27
12/31
Calayo, Tina
CLASP IID, NCT03706833: Edwards PASCAL /IIF Pivotal Clinical Trial

Recruiting
N/A
1247
Europe, Canada, US
Edwards PASCAL System, Transcatheter Mitral Valve repair (TMVr), Abbott Mitraclip System
Edwards Lifesciences
Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
01/25
04/30
MITRAL-II, NCT04408430: The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Recruiting
N/A
210
US
Transseptal ViMAC, ViMAC
Mayra Guerrero
Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
12/24
12/24
NCT05666713: NHLBI Transmural Electrosurgery LeafLet Traversal And Laceration Evaluation (TELLTALE) BASILICA-TAVR Trial

Recruiting
N/A
180
US
TELLTALE BASILICA procedure
National Heart, Lung, and Blood Institute (NHLBI)
Valvular Heart Disease, Aortic Valve Failure
03/25
03/25
Zahr, Firars
MITRAL-II, NCT04408430: The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Recruiting
N/A
210
US
Transseptal ViMAC, ViMAC
Mayra Guerrero
Mitral Annular Calcification, Mitral Stenosis, Mitral Regurgitation, Mitral Valve Disease
12/24
12/24

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