Text Size

OVATIO CRT and SITUS OTW LV Lead Post Approval Study

This study is currently recruiting participants.
Verified March 2012 by ELA Medical, Inc.
Sponsor:
Information provided by (Responsible Party):
ELA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00795873
First received: November 20, 2008
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Resource links provided by NLM:

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

Further study details as provided by ELA Medical, Inc.:

Primary Outcome Measures:
  • SITUS OTW LV lead complication free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • System complication free rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2260
Study Start Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795873

Contacts
Contact: Gwen Gimmestad 763-519-9465 gwen.gimmestad@sorin.com

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

No publications provided

Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00795873     History of Changes
Other Study ID Numbers: ITAC07
Study First Received: November 20, 2008
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013