Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 28, 2008
April 11, 2013
August 2008
April 2012   (final data collection date for primary outcome measure)
Number of Positive Twave Studies and Concurrent Positive Optivol Measurement [ Time Frame: upto 3 years ] [ Designated as safety issue: No ]
We wanted to examine whether positive Optivol status corresponded to a higher likelihood of a positive T wave study. The T wave alternans result is determined by a proprietary device that measures T wave and reports the result as negative, positive, or indeterminate. The Optivol measurement is obtained through transthoracic impedance values in the implanted device. We investigated the correlation between Optivol status and T wave alternans status.
Not Provided
Complete list of historical versions of study NCT00669682 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
T-wave Alternans and Intrathoracic Impedance Measurements
T-wave Alternans and Intrathoracic Impedance Measurements

T-wave alternans is a test that is currently being used to risk stratify patients with structural heart disease for sudden cardiac death. The mechanism of T-wave alternans is unclear, but may share a common abnormality with conditions of cardiac fluid overload such as heart failure, which is altered intracellular calcium handling. Current Medtronic implantable defibrillators have the capability of monitoring cardiac fluid status via transthoracic impedance measurements.

The purpose of this study is to determine if a correlation exists between T-wave alternans status and cardiac volume status, as determined by transthoracic impedance measurements. Secondarily, the study seeks to examine the relationship between arrhythmia frequency and T-wave alternans or cardiac volume status.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Class III or IV heart failure patients

  • Congestive Heart Failure
  • Arrhythmias
Other: Congestive heart failure
Spontaneous occurrence of fluid overload.
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.
Intervention: Other: Congestive heart failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Class III or IV heart failure patients with a chronically implanted Medtronic biventricular defibrillator system capable of monitoring intrathoracic fluid volume.

Exclusion Criteria:

  • no active ischemia or pulmonary edema, atrial fibrillation, complete heart block
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669682
AAAC5529
No
Jose M. Dizon, Columbia University
Columbia University
Medtronic
Principal Investigator: Jose M Dizon, MD Columbia University
Columbia University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP