OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00795873

Enrollment

2260

Registered

2008-11-21

Start date

2008-12-31

Completion date

Unknown

Last updated

2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, cardiac resynchronization therapy

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
SITUS OTW LV lead complication free rate	5 years

Secondary

Measure	Time frame
System complication free rate	6 months

Countries

United States

Outcome results