OVATIO CRT and SITUS OTW LV Lead Post Approval Study
1 other identifier
observational
2,260
1 country
33
Brief Summary
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedSeptember 18, 2013
March 1, 2012
November 20, 2008
September 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SITUS OTW LV lead complication free rate
5 years
Secondary Outcomes (1)
System complication free rate
6 months
Eligibility Criteria
Heart failure patients needing CRT therapy
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Advanced Cardiac Specialists
Mesa, Arizona, 85201, United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85205, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206, United States
Cardiovascular Medical Group of Southern California
Beverly Hills, California, 90210, United States
Center of Interventional Cardiology
Encino, California, 91436, United States
Pacific Arrhythmia Service
La Mesa, California, 91942, United States
Walter Kerwin, M.D., AMC
Los Angeles, California, 90048, United States
Payam Robert Yashar, M.D. Inc.
Los Angeles, California, 90067, United States
Valley Regional Arrhythmia Center
Tarzana, California, 91356, United States
High Desert Heart Institute Medical Corp.
Victorville, California, 92395, United States
Delaware Cardiovascular Associates
Wilmington, Delaware, 19958, United States
Florida Institute for Cardiovascular Care
Hollywood, Florida, 33021, United States
Electrophysiology Consultants of Florida
Miami Beach, Florida, 33140, United States
Central Gerogia Heart Clinic
Macon, Georgia, 31201, United States
Oschner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Primary Care Cardiology Research
Ayer, Massachusetts, 01432-1124, United States
Internal Medicine & Cardiology Associates of SE New England, PC
Fall River, Massachusetts, 02720, United States
Clipper Cardiovascular Associates
Newburyport, Massachusetts, 01950, United States
Jackson Cardiology Associates, P.A.
Jackson, Mississippi, 39216, United States
Atul Prakash, M.D.
Clifton, New Jersey, 07012, United States
Cross County Cardiology
Edgewater, New Jersey, 07020, United States
Hudson Heart Group, PC
Guttenberg, New Jersey, 07093, United States
Cardiovascular Associates of Mountainside, PA
Mountainside, New Jersey, 07092, United States
Joaquim J Correia, MD LLC
Newark, New Jersey, 07105, United States
NJ Heart
Newark, New Jersey, 07105, United States
Divagno Cardiology
Rochelle Park, New Jersey, 07662, United States
The Heartcare Center
Saddle Brook, New Jersey, 07663, United States
Clinical Cardiovascular Specialists
Columbus, Ohio, 43214, United States
Toledo Clinic Inc.
Toledo, Ohio, 43623, United States
Cardiovascular Consultants, Inc.
Tulsa, Oklahoma, 74136, United States
Cardiac Consultants, PC
Lancaster, Pennsylvania, 17604-3200, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Midlands Cardiology Associates
Columbia, South Carolina, 29223, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 21, 2008
Study Start
December 1, 2008
Last Updated
September 18, 2013
Record last verified: 2012-03