MitraClip NT System Post-marketing Surveillance Study - Japan

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03500692
• Collaborator: Abbott (Industry)
• Enrollment: 500
• Locations: 40
• Actual Duration (Months): 47.7
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation; Mitral Valve Regurgitation	Device: MitraClip NT System

Detailed Description

This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.

Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.

Study Design

• Study Type: Observational
• Actual Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: MitraClip NT System Post -Marketing Surveillance Study
• Actual Study Start Date: Apr 2, 2018
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Mar 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
MitraClip NT System Percutaneous mitral valve repair using MitraClip NT System	Device: MitraClip NT System; Percutaneous mitral valve repair using MitraClip NT System

Outcome Measures

Primary Outcome Measures

1. Single Leaflet Device Attachment (SLDA) Rate [up to 30 Days]

   SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device

2. No of Participants With Acute Procedural Success (APS) [up to 7 days (Discharge visit) from Procedure date]

   APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Refer to MitraClip IFU

Exclusion Criteria: Refer to MitraClip IFU

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nagoya Heart Center	Nagoya	Aichi	Japan	461-0045
2	Toyohashi Heart Center	Toyohashi	Aichi	Japan	441-8530
3	New Tokyo Hospital	Matsudo	Chiba	Japan	270-2232
4	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu	Chiba	Japan	279-0001
5	Ehime Prefectural Central Hospital	Matsuyama	Ehime	Japan	790-0024
6	Kyushu University Hospital	Fukuoka-shi	Fukuoka	Japan	812-8582
7	Kokura Memorial Hospital	Kitakyushu	Fukuoka	Japan	802-8555
8	Asahikawa Medical University Hospital	Asahikawa	Hokkaido	Japan	078-8510
9	Hokkaido University Hospital	Sapporo	Hokkaido	Japan	060-8648
10	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo	Japan	660-8550
11	Hyogo Brain and Heart Center	Himeji	Hyogo	Japan	670-0981
12	University of Tsukuba Hospital	Tsukuba	Ibaraki	Japan	305-8576
13	Iwate Medical University Hospital	Morioka	Iwate	Japan	020-8505
14	Tokai University Hospital	Isehara	Kanagawa	Japan	259-1193
15	Shonan Kamakura General Hospital	Kamakura	Kanagawa	Japan	247-8533
16	St. Marianna Medical University Hospital	Kawasaki	Kanagawa	Japan	216-8511
17	Saiseikai Yokohamashi Tobu Hospital	Yokohama	Kanagawa	Japan	230-8765
18	Saiseikai Kumamoto Hospital	Kumamoto-shi	Kumamoto	Japan	861-4193
19	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto	Japan	602-8566
20	Sendai Kousei Hospital	Sendai-shi	Miyagi	Japan	980-0873
21	Miyazaki Medical Association Hospital	Miyazaki-shi	Miyazaki	Japan	880-0834
22	Kurashiki Central Hospital	Kurashiki	Okayama	Japan	710-8602
23	The Sakakibara Heart Institute of Okayama	Okayama-shi	Okayama	Japan	700-0804
24	Kishiwada Tokushukai Hospital	Kishiwada	Osaka	Japan	596-0042
25	Osaka City University Hospital	Osaka-shi	Osaka	Japan	545-8586
26	Osaka General Medical Center	Osaka-shi	Osaka	Japan	558-8558
27	Osaka University Hospital	Suita-shi	Osaka	Japan	565-0871
28	National Cerebral and Cardiovascular Center	Suita-shi	Osaka	Japan	565-8565
29	Saitama Medical University International Medical Center	Hidaka	Saitama	Japan	350-1298
30	Shizuoka General Hospital	Shizuoka-shi	Shizuoka	Japan	420-8527
31	Juntendo University Hospital	Bunkyo	Tokyo	Japan	113-8431
32	The University of Tokyo Hospital	Bunkyo	Tokyo	Japan	113-8655
33	Mitsui Memorial Hospital	Chiyoda	Tokyo	Japan	101-8643
34	Sakakibara Heart Institute	Fuchū	Tokyo	Japan	183-0003
35	Teikyo University Hospital	Itabashi	Tokyo	Japan	173-8606
36	Keio University Hospital	Shinjuku-Ku	Tokyo	Japan	160-8582
37	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo	Japan	162-8666
38	Tottori University Hospital	Yonago	Tottori	Japan	683-8504
39	Toyama University Hospital	Toyama-shi	Toyama	Japan	930-0194
40	Tokushima Red Cross Hospital	Tokushima		Japan	773-8502

Sponsors and Collaborators

• Abbott Medical Devices
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jan 4, 2018
• Statistical Analysis Plan - Jun 25, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03500692
• Other Study ID Numbers: 17-519
• First Posted: Apr 18, 2018
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Abbott Medical Devices: Mitral Valve Regurgitation; MitraClip; MitraClip NT; Japan MitraClip NT Postmarketing Surveillance
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	A total of 500 subjects were enrolled at 40 sites April 2, 2018 to March 31, 2020.

Arm/Group Title	MitraClip NT System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
Period Title: Overall Study
STARTED	500
COMPLETED	391
NOT COMPLETED	109

Baseline Characteristics

Arm/Group Title	MitraClip NT System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
Overall Participants	500
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	77.92 (9.48)
Sex: Female, Male (Count of Participants)
Female	206 41.2%
Male	294 58.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	500 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Japan	500 100%
Height (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	156.96 (10.02)
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	52.05 (10.68)
Body Mass Index (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	21.01 (3.22)
Society of Thoracic Surgeons (STS) Score (Percentage of Expected Mortality) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of Expected Mortality]	11.95 (9.66)
Cardiovascular History (Count of Participants)
Dyslipidemia	216 43.2%
Hypertension	300 60%
Prior Transient Ischemic Attack (TIA)	13 2.6%
Prior Cerebrovascular Accident (CVA)	89 17.8%
Prior Myocardial Infarction	124 24.8%
Cardiac Arrhythmia	358 71.6%
Atrial Fibrillation	316 63.2%
Cardiac Intervention History (Count of Participants)
Prior Cardiac Surgeries	89 17.8%
Prior Cardiac Interventions	142 28.4%
CRT/CRT-D	86 17.2%
Co-Morbidity (Count of Participants)
Currently Smoking	30 6%
Diabetes	144 28.8%
Renal Failure	244 48.8%
Chronic Lung Diesase	77 15.4%
Peripheral Artery Disease	56 11.2%
Prior Major Bleeding	13 2.6%
Cirrhosis	6 1.2%
Cancer	66 13.2%
Heart Valve Intervention (Count of Participants)
Count of Participants [Participants]	28 5.6%
Prior Heart Failure Hospitalization Within 1 year (Count of Participants)
Count of Participants [Participants]	320 64%
Baseline Etiology of Mitral Regurgitation (Count of Participants)
Degenerative MR Only	126 25.2%
Functional MR Only	358 71.6%
Mixed	16 3.2%
Baseline Effective Regurgitant Orifice Area (cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm^2]	0.40 (0.26)
Regurgitant Volume (mL/beat) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/beat]	58.04 (27.61)
Left Ventricular Ejection Fraction (LVEF) (Percentage Of Ejection Fraction) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage Of Ejection Fraction]	46.10 (14.93)
Left Ventricular End Systolic Volume (LVESV) (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	93.54 (64.43)
Left Ventricular End Diastolic Volume (LVEDV) (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	160.26 (75.31)
Serum Creatinine (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	1.71 (1.54)
Brain Natriuretic Peptide (BNP) (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	564.89 (765.45)
N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) (Pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pg/mL]	6935.60 (17888.88)

Outcome Measures

1. Primary Outcome

Title	Single Leaflet Device Attachment (SLDA) Rate
Description	SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Time Frame	up to 30 Days

Outcome Measure Data

Analysis Population Description

All subjects with available data were included for analysis.

Arm/Group Title	MitraClip NT System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
Measure Participants	497
Number [percentage of SLDAs]	1.21

2. Primary Outcome

Title	No of Participants With Acute Procedural Success (APS)
Description	APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame	up to 7 days (Discharge visit) from Procedure date

Outcome Measure Data

Analysis Population Description

All subjects with available data were used for analysis.

Arm/Group Title	MitraClip NT System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
Measure Participants	496
Count of Participants [Participants]	452 90.4%

Adverse Events

Time Frame	This section includes Adverse events reported through 1 year.
Arm/Group Title	MitraClip NT System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip NT System MitraClip NT System: Percutaneous mitral valve repair using MitraClip NT System
All Cause Mortality
	MitraClip NT System
	Affected / at Risk (%)	# Events
Total	76/500 (15.2%)
Serious Adverse Events
	MitraClip NT System
	Affected / at Risk (%)	# Events
Total	245/500 (49%)
Blood and lymphatic system disorders
Anaemia	3/500 (0.6%)	3
Disseminated Intravascular Coagulation	1/500 (0.2%)	1
Haemolytic Anaemia	1/500 (0.2%)	1
Hypochromic Anaemia	1/500 (0.2%)	1
Iron Deficiency Anaemia	1/500 (0.2%)	1
Cardiac disorders
Angina Pectoris	1/500 (0.2%)	1
Angina Unstable	1/500 (0.2%)	1
Aortic Valve Stenosis	1/500 (0.2%)	1
Arrhythmia	3/500 (0.6%)	3
Atrial Fibrillation	5/500 (1%)	7
Atrial Tachycardia	2/500 (0.4%)	2
Atrial Thrombosis	1/500 (0.2%)	1
Atrioventricular Block Complete	1/500 (0.2%)	1
Cardiac Arrest	3/500 (0.6%)	3
Cardiac Failure	102/500 (20.4%)	145
Cardiac Failure Congestive	1/500 (0.2%)	1
Cardiac Tamponade	3/500 (0.6%)	3
Cardiogenic Shock	2/500 (0.4%)	2
Chordae Tendinae Rupture	1/500 (0.2%)	1
Coronary Artery Stenosis	1/500 (0.2%)	1
Intracardiac Thrombus	1/500 (0.2%)	1
Mitral Valve Incompetence	21/500 (4.2%)	21
Mitral Valve Prolapse	12/500 (2.4%)	12
Mitral Valve Stenosis	1/500 (0.2%)	1
Myocardial Ischaemia	1/500 (0.2%)	1
Pericardial Effusion	5/500 (1%)	5
Sinus Arrest	1/500 (0.2%)	1
Tricuspid Valve Incompetence	1/500 (0.2%)	1
Ventricular Fibrillation	4/500 (0.8%)	5
Ventricular Tachycardia	8/500 (1.6%)	9
Congenital, familial and genetic disorders
Atrial Septal Defect	8/500 (1.6%)	8
Ear and labyrinth disorders
Vertigo Positional	1/500 (0.2%)	1
Endocrine disorders
Basedow's Disease	1/500 (0.2%)	1
Eye disorders
Cataract	2/500 (0.4%)	2
Glaucoma	1/500 (0.2%)	1
Gastrointestinal disorders
Breath Odour	1/500 (0.2%)	1
Gastric Ulcer	1/500 (0.2%)	1
Gastric Ulcer Haemorrhage	1/500 (0.2%)	1
Ileus	2/500 (0.4%)	2
Intestinal Ischaemia	2/500 (0.4%)	2
Oesophageal Perforation	1/500 (0.2%)	1
Pancreatitis Acute	1/500 (0.2%)	1
General disorders
Death	14/500 (2.8%)	14
Multi-Organ Failure	1/500 (0.2%)	1
Sudden Cardiac Death	1/500 (0.2%)	1
Hepatobiliary disorders
Bile Duct Stone	2/500 (0.4%)	2
Cholangitis Acute	1/500 (0.2%)	1
Cholecystitis Acute	1/500 (0.2%)	1
Hepatic Failure	1/500 (0.2%)	1
Infections and infestations
Appendicitis Perforated	1/500 (0.2%)	1
Bacteraemia	1/500 (0.2%)	1
Bronchopneumonia	1/500 (0.2%)	1
Endocarditis	3/500 (0.6%)	3
Herpes Zoster	2/500 (0.4%)	2
Infection	1/500 (0.2%)	1
Meningitis	1/500 (0.2%)	1
Pneumonia	13/500 (2.6%)	13
Pneumonia Bacterial	1/500 (0.2%)	1
Psoas Abscess	1/500 (0.2%)	1
Pyelonephritis	1/500 (0.2%)	1
Sepsis	5/500 (1%)	5
Septic Shock	2/500 (0.4%)	2
Staphylococcal Infection	1/500 (0.2%)	1
Urinary Tract Infection	2/500 (0.4%)	2
Injury, poisoning and procedural complications
Compression Fracture	3/500 (0.6%)	3
Femoral Neck Fracture	1/500 (0.2%)	1
Femur Fracture	5/500 (1%)	5
Fracture	1/500 (0.2%)	1
Humerus Fracture	1/500 (0.2%)	1
Lumbar Vertebral Fracture	1/500 (0.2%)	1
Pelvic Fracture	1/500 (0.2%)	1
Rib Fracture	1/500 (0.2%)	1
Spinal Cord Injury Cervical	1/500 (0.2%)	1
Subdural Haematoma	2/500 (0.4%)	2
Thoracic Vertebral Fracture	1/500 (0.2%)	1
Vascular Access Complication	1/500 (0.2%)	1
Venous Injury	1/500 (0.2%)	1
Metabolism and nutrition disorders
Dehydration	5/500 (1%)	5
Hyperkalaemia	1/500 (0.2%)	1
Hyponatraemia	1/500 (0.2%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/500 (0.2%)	1
Back Pain	1/500 (0.2%)	1
Bone Pain	1/500 (0.2%)	1
Muscular Weakness	1/500 (0.2%)	1
Osteoarthritis	1/500 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia	1/500 (0.2%)	1
Colon Cancer Metastatic	1/500 (0.2%)	1
Gallbladder Cancer	1/500 (0.2%)	1
Gastric Cancer	1/500 (0.2%)	1
Hepatic Neoplasm	1/500 (0.2%)	1
Lung Neoplasm Malignant	1/500 (0.2%)	1
Pancreatic Carcinoma	1/500 (0.2%)	1
Renal Cancer	1/500 (0.2%)	1
Nervous system disorders
Haemorrhagic Stroke	5/500 (1%)	5
Hepatic Encephalopathy	1/500 (0.2%)	1
Hypoglycaemic Coma	1/500 (0.2%)	1
Intracranial Aneurysm	1/500 (0.2%)	1
Ischaemic Stroke	6/500 (1.2%)	6
Psychiatric disorders
Depression	1/500 (0.2%)	1
Renal and urinary disorders
Azotaemia	1/500 (0.2%)	1
Renal Failure	21/500 (4.2%)	21
Renal Failure Acute	1/500 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/500 (0.2%)	1
Aspiration	1/500 (0.2%)	1
Asthma	2/500 (0.4%)	2
Chronic Obstructive Pulmonary Disease	4/500 (0.8%)	4
Haemothorax	2/500 (0.4%)	2
Interstitial Lung Disease	3/500 (0.6%)	4
Pleural Effusion	2/500 (0.4%)	2
Pneumonia Aspiration	6/500 (1.2%)	6
Respiratory Failure	1/500 (0.2%)	1
Skin and subcutaneous tissue disorders
Henoch-Schonlein Purpura	1/500 (0.2%)	1
Skin Ulcer	1/500 (0.2%)	1
Surgical and medical procedures
Cardiac Pacemaker Replacement	1/500 (0.2%)	1
Haemodialysis	1/500 (0.2%)	1
Vascular disorders
Aortic Dissection	2/500 (0.4%)	2
Arteriosclerosis	2/500 (0.4%)	2
Embolism	2/500 (0.4%)	2
Haemorrhage	15/500 (3%)	15
Peripheral Arterial Occlusive Disease	1/500 (0.2%)	1
Peripheral Embolism	1/500 (0.2%)	1
Thrombosis	2/500 (0.4%)	2
Other (Not Including Serious) Adverse Events
	MitraClip NT System
	Affected / at Risk (%)	# Events
Total	25/500 (5%)
Blood and lymphatic system disorders
Anaemia	2/500 (0.4%)	2
Cardiac disorders
Atrial Fibrillation	1/500 (0.2%)	1
Bradycardia	1/500 (0.2%)	1
Cardiac Failure	1/500 (0.2%)	1
Chordae Tendinae Rupture	1/500 (0.2%)	1
Mitral Valve Incompetence	2/500 (0.4%)	2
Mitral Valve Prolapse	3/500 (0.6%)	3
Mitral Valve Stenosis	4/500 (0.8%)	5
Pericardial Effusion	1/500 (0.2%)	1
Tachycardia	1/500 (0.2%)	1
Ventricular Tachycardia	1/500 (0.2%)	1
Congenital, familial and genetic disorders
Atrial Septal Defect	1/500 (0.2%)	1
General disorders
Pyrexia	1/500 (0.2%)	1
Infections and infestations
Influenza	1/500 (0.2%)	1
Pneumonia	2/500 (0.4%)	2
Injury, poisoning and procedural complications
Concussion	1/500 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	1/500 (0.2%)	1
Vascular disorders
Hypotension	1/500 (0.2%)	1
Peripheral Artery Aneurysm	1/500 (0.2%)	1
Thrombosis	2/500 (0.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.