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Heart FailureNCT00795873

OVATIO CRT and SITUS OTW LV Lead Post Approval Study

An observational study of Heart Failure, run by ELA Medical, Inc. at 33 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
2,260 participants
Where
33 sitesUnited States
Study dates
Dec 2008to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Heart failure patients needing CRT therapy

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Primary Care Cardiology Research

    Ayer, Massachusetts, 01432-1124

  • Cardiovascular Medical Group of Southern California

    Beverly Hills, California, 90210

  • Atul Prakash, M.D.

    Clifton, New Jersey, 07012

  • Midlands Cardiology Associates

    Columbia, South Carolina, 29223

  • Clinical Cardiovascular Specialists

    Columbus, Ohio, 43214

  • Cross County Cardiology

    Edgewater, New Jersey, 07020

  • Center of Interventional Cardiology

    Encino, California, 91436

  • Internal Medicine & Cardiology Associates of SE New England, PC

    Fall River, Massachusetts, 02720

  • Hudson Heart Group, PC

    Guttenberg, New Jersey, 07093

  • Florida Institute for Cardiovascular Care

    Hollywood, Florida, 33021

  • Jackson Cardiology Associates, P.A.

    Jackson, Mississippi, 39216

  • Pacific Arrhythmia Service

    La Mesa, California, 91942

  • Cardiac Consultants, PC

    Lancaster, Pennsylvania, 17604-3200

  • Walter Kerwin, M.D., AMC

    Los Angeles, California, 90048

  • Payam Robert Yashar, M.D. Inc.

    Los Angeles, California, 90067

  • Central Gerogia Heart Clinic

    Macon, Georgia, 31201

  • Advanced Cardiac Specialists

    Mesa, Arizona, 85201

  • Southwest Cardiovascular Associates

    Mesa, Arizona, 85205

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • Electrophysiology Consultants of Florida

    Miami Beach, Florida, 33140

  • Cardiovascular Associates of Mountainside, PA

    Mountainside, New Jersey, 07092

  • Oschner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Joaquim J Correia, MD LLC

    Newark, New Jersey, 07105

  • NJ Heart

    Newark, New Jersey, 07105

  • Clipper Cardiovascular Associates

    Newburyport, Massachusetts, 01950

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Divagno Cardiology

    Rochelle Park, New Jersey, 07662

  • The Heartcare Center

    Saddle Brook, New Jersey, 07663

  • Valley Regional Arrhythmia Center

    Tarzana, California, 91356

  • Toledo Clinic Inc.

    Toledo, Ohio, 43623

  • Cardiovascular Consultants, Inc.

    Tulsa, Oklahoma, 74136

  • High Desert Heart Institute Medical Corp.

    Victorville, California, 92395

  • Delaware Cardiovascular Associates

    Wilmington, Delaware, 19958

Other trials in United States

About this study

Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.

Conditions
Heart Failure
Keywords
Heart failure, cardiac resynchronization therapy
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SITUS OTW LV lead complication free rate

    Measured: 5 years

Secondary outcomes (1)

  1. System complication free rate

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2008 (estimated)
  2. Study startDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00795873
Sponsor's protocol ID
ITAC07
Status last verified
Mar 2012
First submitted
20 Nov 2008
Last updated
18 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by ELA Medical, Inc. at 33 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SITUS OTW LV lead complication free rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00795873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.

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