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EVEREST II Pivotal Study High Risk Registry (HRR) (HRR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01940120
First received: September 3, 2013
Last updated: November 21, 2016
Last verified: July 2016
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Intervention: Device: Percutaneous mitral valve repair using MitraClip implant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
To get enroll into the registry patient had to who met the eligibility criteria laid down in the protocol had to sign an informed consent and undergo MitraClip procedure. Investigational sites were various hospitals, Medical center in the Unites States. Screening period: Jan, 2007-2008. Enrollment period: Feb 14, 2007- Jan 30, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Risk Registry Arm Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.

Participant Flow:   Overall Study
    High Risk Registry Arm
STARTED   78 
COMPLETED   34 
NOT COMPLETED   44 
Death                33 
Withdrawal by Subject                7 
Lost to Follow-up                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Risk Registry Arm Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.

Baseline Measures
   High Risk Registry Arm 
Overall Participants Analyzed 
[Units: Participants]
 78 
Age 
[Units: Years]
Mean (Standard Deviation)
 76.7  (9.8) 
Age, Customized 
[Units: Participants]
 
18-75 years   30 
>75 years   48 
Gender 
[Units: Participants]
Count of Participants
 
Female      29  37.2% 
Male      49  62.8% 
Region of Enrollment 
[Units: Participants]
 
United States   77 
Canada   1 
Predicted Surgical Mortality [1] 
[Units: Probability percentage]
Mean (Standard Deviation)
 18.2  (8.0) 
[1]

The Society of Thoracic Surgeons' risk models predict the risk of operative mortality & morbidity after adult cardiac surgery.

Risk models were developed for nine specific endpoints, including operative mortality.Operative mortality includes both (1) all deaths occurring during the hospitalization, even if after 30 days (2) deaths occurring after discharge, but within 30 days of the procedure.

Therefore, a patient’s mortality risk score is defined as the patient’s predicted risk of operative mortality as calculated by the specific operative mortality statistical model.

LV Measurement 
[Units: mL]
Mean (Standard Deviation)
 
Left Ventricular End Diastolic Volume (LVEDV)   166.5  (50.7) 
Left Ventricular End Systolic Volume (LVESV)   79.9  (42.7) 
LV Measurement 
[Units: Cm]
Mean (Standard Deviation)
 
Left Ventricular Internal Diameter Diastole(LVIDd)   5.6  (0.7) 
Left Ventricular Internal Diameter Systole (LVIDs)   3.9  (1.1) 
36-Item Short Form Health Survey (SF-36) Quality of Life [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 
Physical Health (PCS)   31.6  (9.1) 
Mental Health (MCS)   44.2  (12.6) 
[1] The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Higher scores represent better self-perceived health. The PCS & MCS norms for 65-75 year olds are 44 and 52, while the norms for CHF population are 31 and 46, respectively.
NYHA Functional Class [1] 
[Units: Participants]
 
NYHA Functional Class I   0 
NYHA Functional Class II   8 
NYHA Functional Class III   47 
NYHA Functional Class IV   23 
[1]

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest & discomfort is increased with physical activity.

Number of patients hospitalized for CHF during 12 months before enrollment 
[Units: Participants]
 
Number of patients hospitalized for CHF   33 
Number of patients not hospitalized for CHF   45 
Number of CHF events leading to hospitalizations during 12 months before enrollment 
[Units: Events]
 51 
Number of hospitalization days for CHF at 12 months before enrollment 
[Units: Days]
Mean (Standard Deviation)
 6.0  (4.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mortality   [ Time Frame: 30 days ]

2.  Primary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class   [ Time Frame: 30 days ]

3.  Primary:   Composite Functional and Structural Measures - Freedom From Death   [ Time Frame: 12 months ]

4.  Primary:   Composite Functional and Structural Measures - Freedom From Death and MR >2+   [ Time Frame: 12 months ]

5.  Primary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class   [ Time Frame: 12 months ]

6.  Primary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36   [ Time Frame: 12 months ]

7.  Primary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - End Diastolic/Systolic Volume   [ Time Frame: 12 months ]

8.  Primary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function - Internal Dimension   [ Time Frame: 12 months ]

9.  Primary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months   [ Time Frame: 12 months ]

10.  Primary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months   [ Time Frame: 12 months ]

11.  Secondary:   Number of Participants Experiencing Major Adverse Events (MAE)   [ Time Frame: 30 days ]

12.  Secondary:   Number of Participants Experiencing Major Vascular Complications   [ Time Frame: 30 days ]

13.  Secondary:   Non-cerebral Thromboembolism   [ Time Frame: 30 days ]

14.  Secondary:   Endocarditis   [ Time Frame: 30 days ]

15.  Secondary:   Atrial Septal Defect (ASD)   [ Time Frame: 30 days ]

16.  Secondary:   MAE in Patients Over 75 Years of Age   [ Time Frame: 30 days ]

17.  Secondary:   Regurgitant Volume   [ Time Frame: 30 days ]

18.  Secondary:   Dysrhythmias   [ Time Frame: 30 days ]

19.  Secondary:   Major Bleeding Complications   [ Time Frame: 30 days ]

20.  Secondary:   Clip Implant Rate   [ Time Frame: 30 Days ]

21.  Secondary:   Regurgitant Fraction   [ Time Frame: 30 days ]

22.  Secondary:   High Risk Procedural Success   [ Time Frame: 30 days ]

23.  Secondary:   Mitral Valve Stenosis   [ Time Frame: 30 days ]

24.  Secondary:   Thrombosis   [ Time Frame: 30 days ]

25.  Secondary:   Hemolysis   [ Time Frame: 30 days ]

26.  Secondary:   Procedural Freedom From In-hospital MAE   [ Time Frame: 30 Days ]

27.  Secondary:   MR Severity   [ Time Frame: Discharge ]

28.  Secondary:   Mortality   [ Time Frame: 12 months ]

29.  Secondary:   Dysrhythmias   [ Time Frame: 12 months ]

30.  Secondary:   Durability   [ Time Frame: 12 months ]

31.  Secondary:   Mitral Valve Repair Success   [ Time Frame: 12 months ]

32.  Secondary:   Clinical Durability   [ Time Frame: 12 months ]

33.  Secondary:   Non-cerebral Thromboembolism   [ Time Frame: 12 months ]

34.  Secondary:   Number of Participants Experiencing Major Adverse Events   [ Time Frame: 12 months ]

35.  Secondary:   Endocarditis   [ Time Frame: 12 months ]

36.  Secondary:   Atrial Septal Defect (ASD)   [ Time Frame: 12 months ]

37.  Secondary:   Regurgitant Volume   [ Time Frame: 12 months ]

38.  Secondary:   Regurgitant Fraction   [ Time Frame: 12 months ]

39.  Secondary:   Mitral Valve Stenosis   [ Time Frame: 12 months ]

40.  Secondary:   Major Bleeding Complications   [ Time Frame: 12 months ]

41.  Secondary:   Number of Participants Experiencing Major Vascular Complications   [ Time Frame: 12 months ]

42.  Secondary:   MAE in Patients Over 75 Years of Age   [ Time Frame: 12 months ]

43.  Secondary:   Thrombosis   [ Time Frame: 12 months ]

44.  Secondary:   Mortality Rate   [ Time Frame: 12 months ]

45.  Secondary:   Hemolysis   [ Time Frame: 12 months ]

46.  Secondary:   MR Severity   [ Time Frame: 12 months ]

47.  Secondary:   Freedom From All Cause Mortality   [ Time Frame: 12 months ]

48.  Secondary:   Freedom From Mitral Valve Surgery   [ Time Frame: 12 months ]

49.  Secondary:   Composite Functional and Structural Measures - Freedom From Death   [ Time Frame: 24 months ]

50.  Secondary:   Composite Functional and Structural Measures - Freedom From Death and MR >2+   [ Time Frame: 24 months ]

51.  Secondary:   Freedom From Death and Mitral Valve Surgery   [ Time Frame: 12 months ]

52.  Secondary:   Device Embolization or Single Leaflet Device Attachment   [ Time Frame: 12 months ]

53.  Secondary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)   [ Time Frame: 24 months ]

54.  Secondary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class   [ Time Frame: 24 months ]

55.  Secondary:   Composite Functional and Structural Measures: Clinical Measures of Benefit-Left Ventricular (LV) Function: Left Ventricular Internal Dimension, Diastole (LVIDd), Left Ventricular Internal Dimension, Systole (LVIDs)   [ Time Frame: 24 months ]

56.  Secondary:   Mortality Rate   [ Time Frame: 24 months ]

57.  Secondary:   MR Severity   [ Time Frame: 24 months ]

58.  Secondary:   Freedom From All Cause Mortality   [ Time Frame: 24 months ]

59.  Secondary:   Durability   [ Time Frame: 24 months ]

60.  Secondary:   Clinical Durability   [ Time Frame: 24 months ]

61.  Secondary:   Regurgitant Volume   [ Time Frame: 24 months ]

62.  Secondary:   Regurgitant Fraction   [ Time Frame: 24 months ]

63.  Secondary:   Mitral Valve Repair Success   [ Time Frame: 24 months ]

64.  Secondary:   Freedom From Mitral Valve Surgery   [ Time Frame: 24 months ]

65.  Secondary:   Freedom From Death and Mitral Valve Surgery   [ Time Frame: 24 months ]

66.  Secondary:   Mitral Valve Stenosis   [ Time Frame: 24 months ]

67.  Secondary:   Device Embolization or Single Leaflet Device Attachment   [ Time Frame: 24 months ]

68.  Secondary:   Device Embolization or Single Leaflet Device Attachment   [ Time Frame: 3 years ]

69.  Secondary:   Freedom From All Cause Mortality   [ Time Frame: 3 years ]

70.  Secondary:   Freedom From Mitral Valve Surgery   [ Time Frame: 36 months ]

71.  Secondary:   Freedom From Death and Mitral Valve Surgery   [ Time Frame: 3 years ]

72.  Secondary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class   [ Time Frame: 3 years ]

73.  Secondary:   Mitral Valve Stenosis   [ Time Frame: 3 year ]

74.  Secondary:   MR Severity   [ Time Frame: 3 year ]

75.  Secondary:   Device Embolization or Single Leaflet Device Attachment   [ Time Frame: 4 years ]

76.  Secondary:   Freedom From All Cause Mortality   [ Time Frame: 4 years ]

77.  Secondary:   Mitral Valve Stenosis   [ Time Frame: 4 year ]

78.  Secondary:   MR Severity   [ Time Frame: 4 year ]

79.  Secondary:   Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class   [ Time Frame: 4 years ]

80.  Other Pre-specified:   Post-procedure Length of Hospital Stay   [ Time Frame: Length of Hospital Stay, assessed at 30 days ]

81.  Other Pre-specified:   Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time   [ Time Frame: Length of ICU/CCU stay, assessed at 30 Days ]

82.  Other Pre-specified:   Incidence of Discharge to a Nursing Home or Skilled Nursing Facility   [ Time Frame: 30 Days ]

83.  Other Pre-specified:   Number of Days Re-hospitalized for CHF   [ Time Frame: 12 months ]

84.  Other Pre-specified:   Hospital Re-Admissions for Congestive Heart Failure (CHF)   [ Time Frame: 12 months ]

85.  Other Pre-specified:   Incidence of New Coumadin Use   [ Time Frame: 30 days ]

86.  Other Pre-specified:   Incidence of New Coumadin Use   [ Time Frame: 6 months ]

87.  Other Pre-specified:   Incidence of New Coumadin Use   [ Time Frame: 12 months ]

88.  Other Pre-specified:   Mitral Valve Index   [ Time Frame: 30 days ]

89.  Other Pre-specified:   Mitral Valve Index   [ Time Frame: 12 months ]

90.  Other Pre-specified:   Cardiac Index   [ Time Frame: 30 Days ]

91.  Other Pre-specified:   Cardiac Index   [ Time Frame: 12 months ]

92.  Other Pre-specified:   Cardiac Index   [ Time Frame: 24 months ]

93.  Other Pre-specified:   Cardiac Output   [ Time Frame: 30 Days ]

94.  Other Pre-specified:   Cardiac Output   [ Time Frame: 12 months ]

95.  Other Pre-specified:   Cardiac Output   [ Time Frame: 24 months ]

96.  Other Pre-specified:   Mitral Valve Area: By Planimetry   [ Time Frame: 30 days ]

97.  Other Pre-specified:   Mitral Valve Area: By Planimetry   [ Time Frame: 12 months ]

98.  Other Pre-specified:   Mitral Valve Area: By Planimetry   [ Time Frame: 24 months ]

99.  Other Pre-specified:   Mitral Valve Area: By Planimetry   [ Time Frame: 3 year ]

100.  Other Pre-specified:   Mitral Valve Area: By Planimetry   [ Time Frame: 4 year ]

101.  Other Pre-specified:   Mitral Valve Area: By Pressure Half-time   [ Time Frame: 30 days ]

102.  Other Pre-specified:   Mitral Valve Area: By Pressure Half-time   [ Time Frame: 12 months ]

103.  Other Pre-specified:   Mitral Valve Area: By Pressure Half-time   [ Time Frame: 24 months ]

104.  Other Pre-specified:   Mitral Valve Area Index: by Pressure-Half Time Formula   [ Time Frame: 30 days ]

105.  Other Pre-specified:   Mitral Valve Area Index : By Pressure Half-time Formula   [ Time Frame: 12 months ]

106.  Other Pre-specified:   Mitral Valve Area Index : By Pressure Half-time Formula   [ Time Frame: 24 months ]

107.  Other Pre-specified:   Mitral Valve Area Index: by Planimetry   [ Time Frame: 30 days ]

108.  Other Pre-specified:   Mitral Valve Area Index : By Planimetry   [ Time Frame: 12 months ]

109.  Other Pre-specified:   Mitral Valve Area Index : By Planimetry   [ Time Frame: 24 months ]

110.  Other Pre-specified:   Transvalvular Mitral Valve Gradient   [ Time Frame: 30 days ]

111.  Other Pre-specified:   Transvalvular Mitral Valve Gradient   [ Time Frame: 12 months ]

112.  Other Pre-specified:   Transvalvular Mitral Valve Gradient   [ Time Frame: 24 months ]

113.  Other Pre-specified:   Transvalvular Mitral Valve Gradient   [ Time Frame: 3 year ]

114.  Other Pre-specified:   Transvalvular Mitral Valve Gradient   [ Time Frame: 4 year ]

115.  Other Pre-specified:   Incidence of Mitral Valve Replacement   [ Time Frame: 12 months ]

116.  Other Pre-specified:   Incidence of Mitral Valve Replacement   [ Time Frame: 24 months ]

117.  Other Pre-specified:   Incidence of Mitral Valve Replacement   [ Time Frame: 3 year ]

118.  Other Pre-specified:   Incidence of Mitral Valve Replacement   [ Time Frame: 4 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chithra Sangli
Organization: Abbott Vascular Structural Heart (formerly Evalve, Inc.)
phone: 650-430-1329
e-mail: chithra.sangli@av.abbott.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01940120     History of Changes
Other Study ID Numbers: 0401A
Study First Received: September 3, 2013
Results First Received: December 10, 2013
Last Updated: November 21, 2016