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

November 26, 2013 updated by: ELA Medical, Inc.

Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Detailed Description

ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality.

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 (NYHA Class III or IV).

Quality of life, adverse events and device success will be analyzed and reported.

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Serum creatinine above 3.0 mg/dL
  • Serum hepatic functions at or above three times the upper normal limit
  • Cerebrovascular event within the previous three months
  • Inability to walk or other physical impediments which might prevent the patient from completing a maximum, symptom-limited treadmill test
  • Age of less than 18 years
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ELA Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITAC06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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