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Pivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209274
First Posted: September 21, 2005
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Evalve
Results First Submitted: December 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Interventions: Device: Percutaneous mitral valve repair using MitraClip implant
Procedure: Mitral valve repair or replacement surgery

  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
The EVEREST II RCT was conducted in patients who were indicated for and could undergo mitral valve surgery. A total of 279 patients were enrolled at United States & Canada investigational sites between Aug 5,2005 to Sep 17,2008 time period. The subjects were randomized to Device group (n=184; MitraClip) &Control group (n=95;Mitral Valve Surgery).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as “randomized not treated” (RNT). All RNT patients except one withdrew from the trial.

Reporting Groups
  Description
Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant.
Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.

Participant Flow:   Overall Study
    Device Group (MitraClip Device)   Control Group (Mitral Valve Surgery)
STARTED   184   95 
COMPLETED   112   50 
NOT COMPLETED   72   45 
Missed visit                9                3 
Death                28                13 
Withdrawal by Subject                29                14 
Randomized not treated (RNT)                6                15 



  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
Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant.
Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Total Total of all reporting groups

Baseline Measures
   Device Group (MitraClip Device)   Control Group (Mitral Valve Surgery)   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   95   279 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.3  (12.8)   65.7  (12.9)   66.7  (12.8) 
Age, Customized 
[Units: Participants]
     
18-75 years   129   69   198 
>75 years   55   26   81 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      69  37.5%      32  33.7%      101  36.2% 
Male      115  62.5%      63  66.3%      178  63.8% 
Region of Enrollment 
[Units: Participants]
     
United States   177   93   270 
Canada   7   2   9 
NYHA Functional Class [1] 
[Units: Participants]
     
NYHA Functional Class I   17   19   36 
NYHA Functional Class II   73   31   104 
NYHA Functional Class III   82   41   123 
NYHA Functional Class IV   12   4   16 
[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.
Mitral regurgitation (MR) 
[Units: Participants]
     
0: None   0   0   0 
1+: Mild   0   0   0 
1+ to 2+: Mild-to-Moderate   0   1   1 
2+: Moderate   8   6   14 
3+: Moderate-to-Severe   130   67   197 
4+: Severe   46   21   67 
Left Ventricular (LV) Measurement 
[Units: mL]
Mean (Standard Deviation)
     
LV End Diastolic Volume (LVEDV)   156.5  (39.0)   159.6  (46.3)   158.05  (42.65) 
LV End Systolic Volume (LVESV)   63.5  (25.5)   63.8  (28.9)   63.65  (27.20) 
Left Ventricular (LV) Measurement 
[Units: Cm]
Mean (Standard Deviation)
     
LV internal dimension diastole (LVIDd)   5.5  (0.7)   5.5  (0.7)   5.5  (0.7) 
LV internal dimension systole (LVIDs)   3.7  (0.9)   3.5  (0.8)   3.6  (0.85) 
36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
     
Physical Component Score   41.1  (10.0)   41.9  (11.1)   41.4  (10.3) 
Mental Component Score   47.1  (11.9)   46.6  (12.5)   46.9  (12.0) 
[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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Major Adverse Events (MAE)   [ Time Frame: 30 days ]

2.  Primary:   Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).   [ Time Frame: 12 months ]

3.  Secondary:   Number of Participants With Clip Implant Rate   [ Time Frame: Day 0 ]

4.  Secondary:   Number of Participants With Mitral Valve Stenosis   [ Time Frame: 30 days ]

5.  Secondary:   Number of Participants With Acute Surgical Success   [ Time Frame: 30 Days ]

6.  Secondary:   Number of Participants With Acute Procedural Success   [ Time Frame: 30 Days ]

7.  Secondary:   Number of Participants With Procedural Success   [ Time Frame: 30 days ]

8.  Secondary:   Regurgitant Volume   [ Time Frame: 30 Days ]

9.  Secondary:   Regurgitant Fraction   [ Time Frame: 30 Days ]

10.  Secondary:   Number of Participants With Mitral Valve Repair Success.   [ Time Frame: 12 months ]

11.  Secondary:   Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).   [ Time Frame: 30 days ]

12.  Secondary:   Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.   [ Time Frame: 12 months ]

13.  Secondary:   Number of Participants With Mitral Valve Stenosis   [ Time Frame: 12 months ]

14.  Secondary:   Short Form (SF)-36 Quality of Life Questionnaire.   [ Time Frame: 30 days ]

15.  Secondary:   Short Form (SF)-36 Quality of Life Questionnaire.   [ Time Frame: 12 months ]

16.  Secondary:   Number of Participants With Durability of the MitraClip Device and Surgery.   [ Time Frame: 12 months ]

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

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

19.  Secondary:   Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).   [ Time Frame: 24 months ]

20.  Secondary:   Number of Participants With Freedom From Mitral Valve Surgery/Re-operation   [ Time Frame: 12 months ]

21.  Secondary:   Number of Participants With Durability of the MitraClip Device and Surgery.   [ Time Frame: 12-18 months ]

22.  Secondary:   Number of Participants With Procedural Freedom From MAE.   [ Time Frame: Day 0 ]

23.  Secondary:   Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+   [ Time Frame: 12 months ]

24.  Secondary:   Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation   [ Time Frame: 12 months ]

25.  Secondary:   Number of Participants With Mitral Valve Stenosis   [ Time Frame: 24 months ]

26.  Secondary:   Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment   [ Time Frame: 12 months ]

27.  Secondary:   Number of Participants With Mitral Valve Repair Success.   [ Time Frame: 24 months ]

28.  Secondary:   Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.   [ Time Frame: 24 months ]

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

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

31.  Secondary:   Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation   [ Time Frame: 24 months ]

32.  Secondary:   Number of Participants With Durability of the MitraClip Device and Surgery.   [ Time Frame: 18-24 months ]

33.  Secondary:   Number of Participants With Durability of the MitraClip Device and Surgery.   [ Time Frame: 24 months-3 year ]

34.  Secondary:   Number of Participants With Freedom From Mitral Valve Surgery/Re-operation   [ Time Frame: 24 months ]

35.  Secondary:   Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+   [ Time Frame: 3 years ]

36.  Secondary:   Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+   [ Time Frame: 24 months ]

37.  Secondary:   Number of Participants With Freedom From Mitral Valve Surgery/Re-operation   [ Time Frame: 3 years ]

38.  Secondary:   Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation   [ Time Frame: 3 years ]

39.  Secondary:   Number of Participants With Mitral Valve Stenosis   [ Time Frame: 3 years ]

40.  Secondary:   Number of Participants With Mitral Valve Stenosis   [ Time Frame: 4 years ]

41.  Secondary:   Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment   [ Time Frame: 12 months to 4 years ]

42.  Secondary:   Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment   [ Time Frame: 12 months to 3 years ]

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

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

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

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

47.  Secondary:   Number of Participants With MR Severity   [ Time Frame: 30 days ]

48.  Secondary:   Number of Participants With MR Severity   [ Time Frame: 12 months ]

49.  Secondary:   Number of Participants With MR Severity   [ Time Frame: 24 months ]

50.  Secondary:   Number of Participants With MR Severity   [ Time Frame: 3 years ]

51.  Secondary:   Number of Participants With MR Severity   [ Time Frame: 4 years ]

52.  Secondary:   Left Ventricular Status- LVEDV, LVESV   [ Time Frame: 30 days ]

53.  Secondary:   Left Ventricular Status- LVEDV, LVESV   [ Time Frame: 12 months ]

54.  Secondary:   Left Ventricular Status- LVEDV, LVESV   [ Time Frame: 24 months ]

55.  Secondary:   Left Ventricular Status- LVEDV, LVESV   [ Time Frame: 3 years ]

56.  Secondary:   Left Ventricular Status- LVEDV, LVESV   [ Time Frame: 4 years ]

57.  Secondary:   Left Ventricular Status- LVEF   [ Time Frame: 30 days ]

58.  Secondary:   Left Ventricular Status- LVEF   [ Time Frame: 12 months ]

59.  Secondary:   Left Ventricular Status- LVEF   [ Time Frame: 24 months ]

60.  Secondary:   Left Ventricular Status- LVEF   [ Time Frame: 3 years ]

61.  Secondary:   Left Ventricular Status- LVEF   [ Time Frame: 4 years ]

62.  Secondary:   Number of Participants With Endocarditis.   [ Time Frame: 30 days ]

63.  Secondary:   Left Ventricular Internal Dimension Systole (LVIDs)   [ Time Frame: 30 days ]

64.  Secondary:   Left Ventricular Internal Dimension Systole (LVIDs)   [ Time Frame: 12 months ]

65.  Secondary:   Left Ventricular Internal Dimension Systole (LVIDs)   [ Time Frame: 2 years ]

66.  Secondary:   Left Ventricular Internal Dimension Systole (LVIDs)   [ Time Frame: 3 years ]

67.  Secondary:   Left Ventricular Internal Dimension Systole (LVIDs)   [ Time Frame: 4 years ]

68.  Secondary:   Left Ventricular Internal Dimension Diastole (LVIDd)   [ Time Frame: 30 days ]

69.  Secondary:   Left Ventricular Internal Dimension Diastole (LVIDd)   [ Time Frame: 12 months ]

70.  Secondary:   Left Ventricular Internal Dimension Diastole (LVIDd)   [ Time Frame: 24 months ]

71.  Secondary:   Left Ventricular Internal Dimension Diastole (LVIDd)   [ Time Frame: 3 years ]

72.  Secondary:   Left Ventricular Internal Dimension Diastole (LVIDd)   [ Time Frame: 4 years ]

73.  Secondary:   Number of Participants With Non-cerebral Thromboembolism.   [ Time Frame: 30 days ]

74.  Secondary:   Post-procedure Length of Hospital Stay   [ Time Frame: 30 Days ]

75.  Secondary:   Number of Participants With Hemolysis   [ Time Frame: 30 days ]

76.  Secondary:   Number of Participants With Major Bleeding Complications.   [ Time Frame: 30 days ]

77.  Secondary:   Number of Participants With Thrombosis.   [ Time Frame: 30 days ]

78.  Secondary:   Number of Participants With Clinically Significant Atrial Septal Defect (ASD).   [ Time Frame: 30 days ]

79.  Secondary:   Number of Participants With Non-cerebral Thromboembolism.   [ Time Frame: 12 months ]

80.  Secondary:   Number of Participants With Major Adverse Events (MAE)   [ Time Frame: 12 months. ]

81.  Secondary:   Number of Participants With Major Vascular Complications   [ Time Frame: 12 months ]

82.  Secondary:   Number of Participants With Major Vascular Complications   [ Time Frame: 30 days ]

83.  Secondary:   Number of Participants With Major Bleeding Complications.   [ Time Frame: 12 months ]

84.  Secondary:   Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration   [ Time Frame: 30 Days ]

85.  Secondary:   Number of Participants With MAE in Patients Over 75 Years of Age.   [ Time Frame: 12 months ]

86.  Secondary:   Number of Participants With Hemolysis   [ Time Frame: 12 months ]

87.  Secondary:   Number of Participants With Thrombosis.   [ Time Frame: 12 months ]

88.  Secondary:   Number of Participants With Endocarditis.   [ Time Frame: 12 months ]

89.  Secondary:   Number of Participants With Clinically Significant Atrial Septal Defect (ASD)   [ Time Frame: 12 months ]

90.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: Baseline ]

91.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: 30 days ]

92.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: 12 months ]

93.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: 24 months ]

94.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: 3 years ]

95.  Secondary:   Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.   [ Time Frame: 4 years ]

96.  Secondary:   New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV   [ Time Frame: 30 days ]

97.  Secondary:   New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV   [ Time Frame: 12 months ]

98.  Secondary:   New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV   [ Time Frame: 2 years ]

99.  Secondary:   New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV   [ Time Frame: 3 years ]

100.  Secondary:   New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV   [ Time Frame: 4 years ]

101.  Secondary:   Number of Participants With Procedural Freedom From In-hospital MAE   [ Time Frame: Day 30 ]

102.  Secondary:   Number of Participants With MAEa Surgery After Device and First Time Surgery Control   [ Time Frame: 30 days ]

103.  Secondary:   Number of Participants With MAE in Patients Over 75 Years of Age.   [ Time Frame: 30 days ]

104.  Secondary:   Number of Participants With Dysrhythmia   [ Time Frame: 30 days ]

105.  Secondary:   Number of Participants With Dysrhythmia   [ Time Frame: 12 months ]

106.  Secondary:   Number of Participants With Hospital Re-admissions   [ Time Frame: 30 days ]

107.  Secondary:   Number of Participants With New Coumadin (Warfarin) Usage   [ Time Frame: 30 days ]

108.  Secondary:   Number of Participants With New Coumadin (Warfarin) Usage   [ Time Frame: 12 months ]

109.  Secondary:   Cardiac Output   [ Time Frame: 30 days ]

110.  Secondary:   Cardiac Index   [ Time Frame: 30 days ]

111.  Secondary:   Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital   [ Time Frame: 30 Days ]

112.  Secondary:   Mitral Valve Area by Planimetry Index   [ Time Frame: 30 Days ]

113.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: 30 Days ]

114.  Secondary:   Transvalvular Mitral Valve Gradient   [ Time Frame: Discharge (≤ 14 days following index procedure] ]

115.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: 30 days ]

116.  Secondary:   Mitral Valve Area by Pressure Half-time Index   [ Time Frame: 30 Days ]

117.  Secondary:   Number of Participants With Incidence of Mitral Valve Replacement   [ Time Frame: 12 months ]

118.  Secondary:   Cardiac Output   [ Time Frame: 12 months ]

119.  Secondary:   Cardiac Index (CI)   [ Time Frame: 12 months ]

120.  Secondary:   Mitral Valve Area by Planimetry Index   [ Time Frame: 12 months ]

121.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: 12 months ]

122.  Secondary:   Mitral Valve Area by Pressure Half-time Index   [ Time Frame: 12 months ]

123.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: 12 months ]

124.  Secondary:   Transvalvular Mitral Mean Pressure Gradient (Mean MVG)   [ Time Frame: 12 months ]

125.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: 24 months ]

126.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: 24 months ]

127.  Secondary:   Mitral Valve Area by Planimetry Index   [ Time Frame: 24 months ]

128.  Secondary:   Mitral Valve Area by Pressure Half-time Index   [ Time Frame: 24 months ]

129.  Secondary:   Transvalvular Mitral Mean Pressure Gradient (Mean MVG)   [ Time Frame: 24 months ]

130.  Secondary:   Number of Participants With Incidence of Mitral Valve Replacement   [ Time Frame: 24 months ]

131.  Secondary:   Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort   [ Time Frame: 24 months ]

132.  Secondary:   Cardiac Output   [ Time Frame: 24 months ]

133.  Secondary:   Cardiac Index   [ Time Frame: 24 months ]

134.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: 3 years ]

135.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: 3 years ]

136.  Secondary:   Transvalvular Mitral Mean Pressure Gradient (Mean MVG)   [ Time Frame: 4 year ]

137.  Secondary:   Transvalvular Mitral Mean Pressure Gradient (Mean MVG)   [ Time Frame: 3 year ]

138.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: 4 years ]

139.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: 4 years ]

140.  Secondary:   Mitral Valve Area by Pressure Half-time   [ Time Frame: At Discharge (≤14 days of index procedure) ]

141.  Secondary:   Mitral Valve Area by Planimetry   [ Time Frame: At Baseline and Discharge (≤14 days of index procedure) ]


  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
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  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: 650-421-6994
e-mail: chithra.sangli@av.abbott.com


Publications of Results:

Other Publications:

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


Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT00209274     History of Changes
Other Study ID Numbers: Protocol #0401
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: December 6, 2013
Results First Posted: September 4, 2017
Last Update Posted: September 4, 2017