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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00305240
Other study ID # 220a
Secondary ID
Status Completed
Phase N/A
First received March 20, 2006
Last updated February 11, 2008
Start date October 2003
Est. completion date February 2007

Study information

Verified date February 2008
Source Medtronic Cardiac Rhythm Disease Management
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. MTWA testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The objective of the study is to prove that if a patient has a negative MTWA test, they will be less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. The results of the study will help doctors to determine which patients would benefit the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.


Recruitment information / eligibility

Status Completed
Enrollment 656
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients indicated for an ICD with a history of heart attacks

- LVEF <= 0.30 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment

Exclusion Criteria:

- Patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (Class I indications)

- Patients who have undergone an electrophysiologic study with ventricular stimulation or a MTWA test within 1 year prior to enrollment

- Patients with medical conditions that preclude the testing required by the Investigational Plan or limit study participation

- Patients unable to complete MTWA testing requirements due to current atrial fibrillation or flutter

- Patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for MTWA testing are not available

- Patients who have experienced an MI within 1 month prior to enrollment

- Patients with advanced cerebrovascular disease per physician's assessment

- Patients classified as NYHA Class IV at time of enrollment

- Patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment

- Patients with a life expectancy of less than 1 year

- Patients with prior ICD

- Patients unable to complete follow-up visits at the study center

- Patients who are enrolled or intend to participate in another clinical study that would compete with the study objectives (assessment will be the responsibility of the Clinical Trial Leader with guidance from the Executive Committee)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
T Wave Alternans Test


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm Disease Management Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demonstrate that the life-threatening ventricular tachyarrhythmic event-free survival probability is greater in patients with a baseline MTWA Negative result as compared to patients with a baseline MTWA Non-Negative (Positive or Indeterminate) result.
Secondary Compare occurrence of all ventricular events between both groups
Secondary Identify predictors of life threatening ventricular arrhythmias
Secondary Calculate occurrence of life threatening ventricular arrhythmias based on last MTWA results
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