OVATIO CRT and SITUS OTW LV Lead Post Approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ELA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00795873
First received: November 20, 2008
Last updated: September 16, 2013
Last verified: March 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795873

  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: September 16, 2013
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 September 22, 2014