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OVATIO CRT and SITUS OTW LV Lead Post Approval Study

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ClinicalTrials.gov Identifier: NCT00795873
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
ELA Medical, Inc.

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

Condition or disease
Heart Failure

Study Type : Observational
Estimated Enrollment : 2260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OVATIO CRT and SITUS OTW LV Lead Post Approval Study
Study Start Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources




Primary Outcome Measures :
  1. SITUS OTW LV lead complication free rate [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. System complication free rate [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients needing CRT therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795873


  Show 33 Study Locations
Sponsors and Collaborators
ELA Medical, Inc.

Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00795873     History of Changes
Other Study ID Numbers: ITAC07
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: March 2012

Keywords provided by ELA Medical, Inc.:
Heart failure
cardiac resynchronization therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases