Clinical Trials
OPTIVOL CARE PATHWAY
Medtronic – Scott Burke, PI – IRB approval pending - OptiVol® Care Pathway Study, a prospective, randomized, multi-center, post-market clinical trial in the United States. Future revisions may be made to include other geographies. The purpose of this clinical trial is to compare monthly versus quarterly review of Cardiac Compass® Trends with OptiVol for initiation of clinical action. Only clinical actions taken based on new information obtained from review of Cardiac Compass Trends with OptiVol will be collected.
SMART AV
Boston Scientific - Michael Rozengarten, PI – Enrollment Open - SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV)
ATHENA
Sanofi Aventis - Michael Rozengarten, PI - Closed - A Placebo-Contorlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients with Atrial Fibrillation/Atrial Flutter (AF/AFL)
CONNECT
Medtronic - Brad Sodowick, PI – Closed – US, post-market study including 150 centers and 2000 patients, following patients for 15 months Eligible devices include ConcertoTM, VirtuosoTM, and other ConexusTM-containing DR-ICD and CRT-D devices when they become commercially available. All market approved leads are eligible.
RELY
Boehringer Ingelheim - Scott Burke, PI – Closed - Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY)
RAPID RF
Guidant – Bradford Sodowick, PI – Closed -The purpose of this study is to collect information from the LATITUDE system and your medical records in order to properly characterize the use of LATITUDE Active Monitoring™ in heart failure patients.
DECODE
Guidant - Bradford Sodowick, PI – Closed -The purpose of this study is to collect information from your LATITUDE system and your medical records. Guidant scientists will use this information to try to develop a way to predict when heart failure symptoms may occur.