T-wave Alternans and Intrathoracic Impedance Measurements

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jose M. Dizon, Columbia University
ClinicalTrials.gov Identifier:
NCT00669682
First received: April 28, 2008
Last updated: April 11, 2013
Last verified: April 2013
Results First Received: February 15, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Congestive Heart Failure
Arrhythmias
Intervention: Other: Congestive heart failure

  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
9 patients enrolled from device clinic between 8/14/08 and 2/11/11

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
na

Reporting Groups
  Description
Group A The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.

Participant Flow:   Overall Study
    Group A  
STARTED     9  
COMPLETED     9  
NOT COMPLETED     0  



  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
Group A The study group will include Class III to IV heart failure patients followed in the device clinic that have a chronically implanted (more than 90 days) Medtronic biventricular defibrillator with the ability to monitor intrathoracic impedance.

Baseline Measures
    Group A  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     7  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  60  ± 10  
Gender  
[units: participants]
 
Female     4  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     9  



  Outcome Measures

1.  Primary:   Number of Positive Twave Studies and Concurrent Positive Optivol Measurement   [ Time Frame: upto 3 years ]


  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 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: Jose' Dizon, MD
Organization: Columbia University
phone: 212-305-8559
e-mail: jmd11@columbia.edu


No publications provided


Responsible Party: Jose M. Dizon, Columbia University
ClinicalTrials.gov Identifier: NCT00669682     History of Changes
Other Study ID Numbers: AAAC5529
Study First Received: April 28, 2008
Results First Received: February 15, 2013
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board