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NeoChord TACT Post-Market Surveillance Registry

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ClinicalTrials.gov Identifier: NCT01784055
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
NeoChord

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Overall All Subjects

Participant Flow:   Overall Study
    Overall
STARTED   126 
COMPLETED   100 
NOT COMPLETED   26 



  Baseline Characteristics

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
Overall All subjects

Baseline Measures
   Overall 
Overall Participants Analyzed 
[Units: Participants]
 126 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed 
[Units: Participants]
 125 
   66  (14) 
[1] One patient did not have baseline information reported
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Participants Analyzed 
[Units: Participants]
 125 
Female      34  27.2% 
Male      91  72.8% 
[1] One patient did not have baseline information reported
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.


  Outcome Measures

1.  Primary:   Procedure Success   [ Time Frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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.


Results Point of Contact:  
Name/Title: Lori E Adels, PhD
Organization: NeoChord, Inc.
phone: 1-952-698-7804
e-mail: ladels@neochord.com



Responsible Party: NeoChord
ClinicalTrials.gov Identifier: NCT01784055     History of Changes
Other Study ID Numbers: 800001-001
First Submitted: January 31, 2013
First Posted: February 5, 2013
Results First Submitted: August 31, 2017
Results First Posted: April 2, 2018
Last Update Posted: April 2, 2018