Clinical trial NCT00795873: OVATIO CRT and SITUS OTW LV Lead Post Approval Study
Official title: OVATIO CRT and SITUS OTW LV Lead Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
cardiac resynchronization therapy
Lead sponsor: ELA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 2260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients needing CRT therapy

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


Eligibility 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

Primary outcomes:
measure: SITUS OTW LV lead complication free rate
timeFrame: 5 years
Secondary outcomes:
measure: System complication free rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Advanced Cardiac Specialists
state: Arizona
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Beverly Hills
country: United States
facility: Cardiovascular Medical Group of Southern California
state: California
city: Encino
country: United States
facility: Center of Interventional Cardiology
state: California
city: La Mesa
country: United States
facility: Pacific Arrhythmia Service
state: California
city: Los Angeles
country: United States
facility: Walter Kerwin, M.D., AMC
state: California
city: Los Angeles
country: United States
facility: Payam Robert Yashar, M.D. Inc.
state: California
city: Tarzana
country: United States
facility: Valley Regional Arrhythmia Center
state: California
city: Victorville
country: United States
facility: High Desert Heart Institute Medical Corp.
state: California
city: Wilmington
country: United States
facility: Delaware Cardiovascular Associates
state: Delaware
city: Hollywood
country: United States
facility: Florida Institute for Cardiovascular Care
state: Florida
city: Miami Beach
country: United States
facility: Electrophysiology Consultants of Florida
state: Florida
city: Macon
country: United States
facility: Central Gerogia Heart Clinic
state: Georgia
city: New Orleans
country: United States
facility: Oschner Clinic Foundation
state: Louisiana
city: Ayer
country: United States
facility: Primary Care Cardiology Research
state: Massachusetts
city: Fall River
country: United States
facility: Internal Medicine & Cardiology Associates of SE New England, PC
state: Massachusetts
city: Newburyport
country: United States
facility: Clipper Cardiovascular Associates
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Cardiology Associates, P.A.
state: Mississippi
city: Clifton
country: United States
facility: Atul Prakash, M.D.
state: New Jersey
city: Edgewater
country: United States
facility: Cross County Cardiology
state: New Jersey
city: Guttenberg
country: United States
facility: Hudson Heart Group, PC
state: New Jersey
city: Mountainside
country: United States
facility: Cardiovascular Associates of Mountainside, PA
state: New Jersey
city: Newark
country: United States
facility: Joaquim J Correia, MD LLC
state: New Jersey
city: Newark
country: United States
facility: NJ Heart
state: New Jersey
city: Rochelle Park
country: United States
facility: Divagno Cardiology
state: New Jersey
city: Saddle Brook
country: United States
facility: The Heartcare Center
state: New Jersey
city: Columbus
country: United States
facility: Clinical Cardiovascular Specialists
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Inc.
state: Ohio
city: Tulsa
country: United States
facility: Cardiovascular Consultants, Inc.
state: Oklahoma
city: Lancaster
country: United States
facility: Cardiac Consultants, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Columbia
country: United States
facility: Midlands Cardiology Associates
state: South Carolina
Study officials:
References: