Optima Coronary Artery Disease (CAD) (Optimal Mechanical Evaluation)

Heart Failure Clinical Trial

Official title:

Optima CAD (Optimal Mechanical Evaluation)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896142
• Other study ID #: 0601112
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: November 21, 2011
• Start date: October 2006

Study information

• Verified date: November 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Ischemic Cardiomyopathy

2. Left ventricular ejection fraction less than 40%

3. Clinical indication for invasive electrophysiology testing

4. Patient is at least 18 years of age

Exclusion Criteria

1. Unstable angina, acute myocardial infarction and/or revascularization procedure within 3 months

2. CVA or TIA within the past 6 months

3. Prosthetic heart valve

4. Patient is status post heart transplant

5. Women who are pregnant or with child -bearing potential and who are not on a reliable form of birth control. Women of child-bearing potential are routinely tested for pregnancy as part of the standard of care prior to EPS procedures being performed.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy

Locations

Country	Name	City	State
United States	UPMC Presybterian	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,