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OpenTrials
Completed

NCT Number: NCT00795873

OVATIO CRT and SITUS OTW LV Lead Post Approval Study

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Cardiac Specialists, Mesa, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. SITUS OTW LV lead complication free rate

    Time frame: 5 years

Secondary outcomes

  1. System complication free rate

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

ELA Medical, Inc.

Industry

Registry information

Important dates

Study start
2008
First posted
Nov 21, 2008
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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