SUMMIT: Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03433274

Collaborator

(none)

958

Enrollment

Locations

Arms

107.5

Anticipated Duration (Months)

12.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prospective, controlled, multicenter clinical investigation with three trial cohorts:

Randomized, Non-repairable, and Severe Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable and Severe MAC cohorts will receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart Heart Valve Diseases Functional Mitral Regurgitation Degenerative Mitral Valve Disease	Device: Tendyne Mitral Valve System Device: MitraClip System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

958 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Actual Study Start Date :

Jun 15, 2018

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Randomized Cohort - Treatment Group Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System	Device: Tendyne Mitral Valve System Mitral valve replacement
Active Comparator: Randomized Cohort - Control Group Treatment of mitral regurgitation within commercially approved MitraClip system indications	Device: MitraClip System Percutaneous mitral valve repair using the MitraClip system.
Experimental: Non-repairable Cohort Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System	Device: Tendyne Mitral Valve System Mitral valve replacement
Experimental: Severe Mitral Annular Calcification (MAC) Cohort Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System	Device: Tendyne Mitral Valve System Mitral valve replacement

Outcome Measures

Primary Outcome Measures

Randomized Cohort [1 year]
Survival free of heart failure hospitalization at 12 months post index procedure
Non-repairable Cohort [1 year]
Survival free of heart failure hospitalization at 12 months post index procedure
Severe Mitral Annular Calcification (MAC) Cohort [1 year]
Survival free of heart failure hospitalization at 12 months post index procedure

Secondary Outcome Measures

Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) [1 year]
Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [1 year]
Change from baseline in health outcomes, as measured by the EQ-5D [1 year]
• Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) [1 year]
Change from baseline in New York Heart Association Classification [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
The local site heart team determines that the subject has been adequately treated per applicable standards
Not a member of a vulnerable population

Exclusion Criteria:

Mitral valvular vegetation or mass
Left ventricular ejection fraction < 25%
Left ventricular end diastolic diameter > 7.0 cm
Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
Aortic valve disease requiring surgery or transcatheter intervention
Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
Subject undergoing hemodialysis due to chronic renal failure
Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princeton Baptist Medical Center	Birmingham	Alabama	United States	35211
2	UAB University Hospital	Birmingham	Alabama	United States	35233
3	Banner-University Medical Center	Phoenix	Arizona	United States	85006
4	HonorHealth Scottsdale Shea Medical Center	Scottsdale	Arizona	United States	85260
5	Fresno Heart Hospital	Fresno	California	United States	93720
6	University of Southern California University Hospital	Los Angeles	California	United States	90033
7	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
8	Sutter Medical Center, Sacramento	Sacramento	California	United States	95816
9	University of California - Davis Medical Center	Sacramento	California	United States	95817
10	San Diego Cardiac Center	San Diego	California	United States	92123
11	University of California at San Francisco	San Francisco	California	United States	94143
12	Stanford Health Care	Stanford	California	United States	94304
13	Los Robles Hospital and Medical Center	Thousand Oaks	California	United States	91360
14	University of Colorado Hospital	Aurora	Colorado	United States	80045
15	Medstar Health Research Institute	Washington	District of Columbia	United States	20010
16	Manatee Memorial Hospital	Bradenton	Florida	United States	34208
17	Morton Plant Hospital	Clearwater	Florida	United States	33756
18	Delray Medical Center	Delray Beach	Florida	United States	33484
19	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
20	Shands at the University of Florida	Gainesville	Florida	United States	32610
21	Baptist Hospital of Miami	Miami	Florida	United States	33176
22	Tallahassee Research Institute	Tallahassee	Florida	United States	32308
23	Cleveland Clinic Florida	Weston	Florida	United States	33331
24	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
25	Emory University Hospital	Atlanta	Georgia	United States	30322
26	Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
27	St. Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
28	Rush University Medical Center	Chicago	Illinois	United States	60640
29	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60543
30	Prairie Education & Research Cooperative	Springfield	Illinois	United States	62701
31	St. Vincent Hospital	Indianapolis	Indiana	United States	46240
32	Cardiovascular Research Institute of Kansas	Wichita	Kansas	United States	67226
33	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
34	Adventist HealthCare White Oak Medical Center	Silver Spring	Maryland	United States	20904
35	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
36	University of Michigan	Ann Arbor	Michigan	United States	48104
37	Henry Ford Hospital	Detroit	Michigan	United States	48202
38	Beaumont Hospital	Royal Oak	Michigan	United States	48073
39	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
40	Mayo Clinic	Rochester	Minnesota	United States	55905
41	St. Luke's Hospital	Kansas City	Missouri	United States	64111
42	St. Louis University Hospital	Saint Louis	Missouri	United States	63110
43	The International Heart Institute of Montana	Missoula	Montana	United States	59802
44	Catholic Medical Center	Manchester	New Hampshire	United States	03102
45	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
46	Robert Wood Johnson University Hospital	New Brunswick	New Jersey	United States	08901
47	Newark Beth Israel Medical Center	Newark	New Jersey	United States	07112
48	Albany Medical College at Albany Medical Center	Albany	New York	United States	12208
49	Southside Hospital	Bay Shore	New York	United States	11706
50	Buffalo General Hospital	Buffalo	New York	United States	14203
51	New York Presbyterian Hospital/ Weill Cornell Medical Center	New York	New York	United States	10021
52	Lenox Hill Hospital	New York	New York	United States	10075
53	Mission Health & Hospitals	Asheville	North Carolina	United States	28801
54	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
55	Novant Health Heart and Vascular Research Institute	Charlotte	North Carolina	United States	28204
56	The Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
57	Oklahoma Heart Institute at Utica	Tulsa	Oklahoma	United States	74104
58	Providence Heart & Vascular Institute	Portland	Oregon	United States	97225
59	Alleghany General Hospital	Pittsburgh	Pennsylvania	United States	15212
60	UPMC Shadyside	Pittsburgh	Pennsylvania	United States	15232
61	Medical University of South Carolina	Charleston	South Carolina	United States	29425
62	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
63	Centennial Medical Center	Nashville	Tennessee	United States	37203
64	St. Thomas Health	Nashville	Tennessee	United States	37205
65	Cardiothoracic & Vascular Surgeons	Austin	Texas	United States	78756
66	Baylor Scott & White Heart and Vascular Hospital	Dallas	Texas	United States	75226
67	Medical City Dallas Hospital	Dallas	Texas	United States	75230
68	Memorial Hermann Hospital	Houston	Texas	United States	77030
69	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
70	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
71	Swedish Medical Center - Heart & Vascular	Seattle	Washington	United States	98122
72	West Virginia University	Morgantown	West Virginia	United States	26506
73	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
74	Ottawa Heart Institute	Ottawa	Ontario	Canada	K1Y 4W7
75	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
76	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
77	The Royal Victoria Hospital	Montreal	Quebec	Canada	H4A 3J1
78	Montreal Heart Institute	Montréal	Quebec	Canada

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Gorav Ailawadi, MD, University of Michigan
Principal Investigator: Jason Rogers, MD, University of California, Davis
Study Director: Ryan Palmer, PhD, Abbott Structural Heart

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT03433274

Other Study ID Numbers:

CS0004-P

First Posted:

Feb 14, 2018

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Cardiovascular Diseases

Mitral Valve Insufficiency

Heart Valve Diseases

Study Results

No Results Posted as of Jun 15, 2022