Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System

NCT00528320 | Unknown

• 1 other identifier: ITAC06
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association \[NYHA\] Class III or IV). Quality of life, adverse events and device success will be analyzed and reported.

Conditions

Congestive Heart Failure (CHF)

Keywords

Congestive Heart Failure; Heart Failure; Cardiac Resynchronization Therapy; ICD; Implantable Cardioverter-Defibrillator; Defibrillator

Interventions

Ovatio CRT DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accepted indication for ICD implant
• Severe heart failure (NYHA Class III or IV) at the time of enrollment
• May have pre-existing ICD, provided subject is on stable, optimal medical regime
• Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
• Left-ventricular ejection fraction (LVEF) of 35% or less

You may not qualify if:

• Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
• Any contraindication for ICD therapy
• Currently implanted with a lead positioned in or through the coronary sinus
• Hypertrophic or obstructive cardiomyopathy
• Acute myocarditis
• Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
• Recent or planned cardiac revascularization or coronary angioplasty
• Correctable valvular disease that is the primary cause of heart failure
• Mechanical tricuspid valve
• Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month
• Systolic blood pressure consistently above 170 mmHg or consistently below 80 mmHg
• Supine resting heart rate exceeding 100 bpm
• Receiving continuous IV infusion of positive inotropic therapy or intermittent therapy (IV infusion) more than twice per week
• Heart transplant recipient
• Primary pulmonary disease of a severity that might limit the patient's ability to perform a treadmill test

Sponsors & Collaborators

• ELA Medical, Inc.: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Last Updated: November 27, 2013

Record last verified: 2013-11