Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (ACTIVE)
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ClinicalTrials.gov Identifier: NCT03016975 |
Recruitment Status :
Active, not recruiting
First Posted : January 11, 2017
Results First Posted : November 9, 2022
Last Update Posted : January 10, 2023
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Sponsor:
Edwards Lifesciences
Information provided by (Responsible Party):
Edwards Lifesciences
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Functional Mitral Regurgitation Mitral Regurgitation Mitral Insufficiency |
Interventions |
Device: Edwards Cardioband System Drug: Guideline Directed Medical Therapy |
Enrollment | 12 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Roll-in | Experimental: Edwards Cardioband System | Control: No Intervention |
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Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment. |
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) | Guideline directed medical therapy (GDMT) |
Period Title: At 30 Days Follow-up | |||
Started | 12 | 0 | 0 |
Completed | 11 | 0 | 0 |
Not Completed | 1 | 0 | 0 |
Reason Not Completed | |||
Subject is a Screen failure | 1 | 0 | 0 |
Period Title: At 6 Months Follow-up | |||
Started | 11 | 0 | 0 |
Completed | 6 | 0 | 0 |
Not Completed | 5 | 0 | 0 |
Reason Not Completed | |||
Death | 2 | 0 | 0 |
Subject withdrawn by investigator | 1 | 0 | 0 |
Re-attempt procedure | 1 | 0 | 0 |
Aborted implant | 1 | 0 | 0 |
Period Title: At 1 Year Follow-up | |||
Started | 6 | 0 | 0 |
Completed | 6 | 0 | 0 |
Not Completed | 0 | 0 | 0 |
Period Title: At 2 Year Follow-up | |||
Started | 6 | 0 | 0 |
Completed | 5 | 0 | 0 |
Not Completed | 1 | 0 | 0 |
Reason Not Completed | |||
Death | 1 | 0 | 0 |
Period Title: At 3 Year Follow-up | |||
Started | 5 | 0 | 0 |
Completed | 3 | 0 | 0 |
Not Completed | 2 | 0 | 0 |
Reason Not Completed | |||
Death | 1 | 0 | 0 |
Withdrawal by Subject | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Roll-in | Experimental: Edwards Cardioband System | Control: No Intervention | Total | |
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Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT). This patient group is treated by physicians requiring additional training prior to beginning randomized cohort enrollment. |
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) | Guideline directed medical therapy (GDMT) | Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 0 | 0 | 12 | |
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Data were not collected for the experimental or control group.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 12 participants | 0 participants | 0 participants | 12 participants | |
71.8 (9.60) | 71.8 (9.60) | ||||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 0 participants | 0 participants | 12 participants | |
Female |
2 16.7%
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2 16.7%
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Male |
10 83.3%
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10 83.3%
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Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 0 participants | 0 participants | 9 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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Black or African American |
1 11.1%
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1 11.1%
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White |
8 88.9%
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8 88.9%
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More than one race |
0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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[1]
Measure Analysis Population Description: Data unavailable for 3 patients
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 0 participants | 0 participants | 12 participants |
12 | 12 | ||||
NYHA Functional Class
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 0 participants | 0 participants | 12 participants | |
Class 1 |
0 0.0%
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0 0.0%
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Class II |
5 41.7%
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5 41.7%
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Class III |
6 50.0%
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6 50.0%
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Class IV |
1 8.3%
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1 8.3%
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[1]
Measure Description:
Measure Description: NYHA Classification - The stages of heart failure:
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Ted Feldman |
Organization: | Edwards Lifesciences |
Phone: | 949-250-2500 |
EMail: | Feldman_Info@edwards.com |
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT03016975 |
Other Study ID Numbers: |
2017-05 |
First Submitted: | January 8, 2017 |
First Posted: | January 11, 2017 |
Results First Submitted: | April 13, 2022 |
Results First Posted: | November 9, 2022 |
Last Update Posted: | January 10, 2023 |