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

History of Changes

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

Hide Participant Flow

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

Hide Baseline Characteristics

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 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide 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.

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.

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

To Top