OVATIO CRT and SITUS OTW LV Lead Post Approval Study

September 16, 2013 updated by: ELA Medical, Inc.
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85205
        • Southwest Cardiovascular Associates
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa
      • Mesa, Arizona, United States, 85201
        • Advanced Cardiac Specialists
    • California
      • Beverly Hills, California, United States, 90210
        • Cardiovascular Medical Group of Southern California
      • Encino, California, United States, 91436
        • Center of Interventional Cardiology
      • La Mesa, California, United States, 91942
        • Pacific Arrhythmia Service
      • Los Angeles, California, United States, 90048
        • Walter Kerwin, M.D., AMC
      • Los Angeles, California, United States, 90067
        • Payam Robert Yashar, M.D. Inc.
      • Tarzana, California, United States, 91356
        • Valley Regional Arrhythmia Center
      • Victorville, California, United States, 92395
        • High Desert Heart Institute Medical Corp.
    • Delaware
      • Wilmington, Delaware, United States, 19958
        • Delaware Cardiovascular Associates
    • Florida
      • Hollywood, Florida, United States, 33021
        • Florida Institute for Cardiovascular Care
      • Miami Beach, Florida, United States, 33140
        • Electrophysiology Consultants of Florida
    • Georgia
      • Macon, Georgia, United States, 31201
        • Central Gerogia Heart Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Clinic Foundation
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432-1124
        • Primary Care Cardiology Research
      • Fall River, Massachusetts, United States, 02720
        • Internal Medicine & Cardiology Associates of SE New England, PC
      • Newburyport, Massachusetts, United States, 01950
        • Clipper Cardiovascular Associates
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Cardiology Associates, P.A.
    • New Jersey
      • Clifton, New Jersey, United States, 07012
        • Atul Prakash, M.D.
      • Edgewater, New Jersey, United States, 07020
        • Cross County Cardiology
      • Guttenberg, New Jersey, United States, 07093
        • Hudson Heart Group, PC
      • Mountainside, New Jersey, United States, 07092
        • Cardiovascular Associates of Mountainside, PA
      • Newark, New Jersey, United States, 07105
        • Joaquim J Correia, MD LLC
      • Newark, New Jersey, United States, 07105
        • NJ Heart
      • Rochelle Park, New Jersey, United States, 07662
        • Divagno Cardiology
      • Saddle Brook, New Jersey, United States, 07663
        • The Heartcare Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Clinical Cardiovascular Specialists
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Cardiovascular Consultants, Inc.
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
        • Cardiac Consultants, PC
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • South Carolina
      • Columbia, South Carolina, United States, 29223
        • Midlands Cardiology Associates

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients needing CRT therapy

Description

Inclusion Criteria:

  • NYHA Class III/IV
  • Stable medical regimen
  • QRS greater than or equal to 130 ms
  • LVEF less than or equal to 35%

Exclusion Criteria:

  • VT of transient or reversible causes
  • Incessant VT
  • Currently implanted with a lead positioned through the coronary sinus (unless it is the SITUS OTW LV lead)
  • Cardiac revascularization or angioplasty within the last month
  • Heart failure due to correctable valve disease
  • Chronic, medially refractory AT
  • Enrolled in another clinical study that may confound the results of this study
  • Life expectancy less than 6 months
  • Inability to understand the purpose of the study or refusal to cooperate
  • Inability or refusal to provide informed consent
  • Unavailable for scheduled follow-up with the implanting practice
  • Sensitivity to 1 mg dexamethasone sodium phosphate
  • Less than 18 years of age
  • 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?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SITUS OTW LV lead complication free rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
System complication free rate
Time Frame: 6 months
6 months

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 Major Dates

Study Start

December 1, 2008

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (Estimate)

November 21, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITAC07

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.

Clinical Trials on Heart Failure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe