Clinical Trials

IMPACT

Biotronik – Michael Rozengarten, PI – Enrollment Open – The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and physician-directed anticoagulation in patients with implanted dual-chamber defibrillators or cardiac resynchronization therapy devices.

SMART AV

Boston Scientific – Michael Rozengarten, PI – Closed – 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.