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OVATIO CRT and SITUS OTW LV Lead Post Approval Study

NCT00795873·33 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

ELA Medical, Inc.

Age

18–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

NYHA Class III/IV
Stable medical regimen
QRS greater than or equal to 130 ms
LVEF less than or equal to 35%

You may not be if

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

The record

StatusCompleted

PhaseNo phase

Taking part2,260

StartedDec 2008

UpdatedSep 18, 2013

Conditions

Where33

Advanced Cardiac Specialists
Mesa, Arizona, United States
Southwest Cardiovascular Associates
Mesa, Arizona, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States

Clareo Health | OVATIO CRT and SITUS OTW LV Lead Post Approval Study