Active Clinical Trials

AdaptResponse

Medtronic – Scott Burke, PI – Medtronic, Inc. is sponsoring the AdaptResponse study; a prospective, randomized, controlled, interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization Therapy (CRT) in heart failure (HF) clinical study. The purpose of this clinical study is to test the hypothesis that market released CRT devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with
normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

CROSS X4

Boston Scientific – Scott Burke, PI – The goal of this study is to evaluate the left ventricular (LV) pacing vectors available in Boston Scientific’s (BSC) FDA-approved quadripolar (X4) CRT-Ds compared to the LV pacing vectors available in St. Jude Medical’s (STJ) CRT-Ds using a quadripolar LV lead.

LSS

Boston Scientific – Eran Zacks, PI – Open – The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its long-term functional integrity and performance.

OPTISURE

St. Jude Medical – Michael Rozengarten, PI – Open – The Optisure Lead Post Approval Study (Optisure Lead Study) is a multi-center post-approval study of the Optisure family of high voltage (HV) leads. The product under study is a St. Jude Medical lead available with a DF1 or DF4 connector, active or passive fixation method and single or dual shocking coils. The goal of this post approval study is to characterize the chronic performance of the St Jude Medical (SJM) Optisure family of right ventricular (RV) HV leads.

ProMRI

BIOTRONIK – Rafael Pena, PI – Open – In the past, patients who needed an MRI scan could not have one if they had been previously implanted with a pacemaker or similar device. The strong electrical and magnetic energy present during an MRI scan could damage certain types of pacemakers. BIOTRONIK is conducting this research study on patients implanted with a BIOTRONIK ProMRI Pacemaker System (specifically, an Entovis pacemaker and one or two Setrox S pacing leads), to prove that an MRI scan can be conducted safely on a patient implanted with this pacemaker system, if certain conditions and precautions are taken.


ACCENT MRI PACEMAKER AND TENDRIL MRI LEAD IDE

St. Jude Medical – Eran Zacks, PI – Closed – IDE study is to evaluate the short and long term safety of the Tendril MRI lead and the Accent MRI pacemaker, together known as the Accent MRI system. There are two parts to this study. One part of the study will look at how the Accent MRI system performs independent of an MRI scan. The second part of the study will look at how the Accent MRI system works after it has undergone an MRI scan .


Previous Clinical Trials

ATHENA

Sanofi Aventis – Michael Rozengarten, PI – 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)

CONFIRM-HF

Jefferson University – Michael Rozengarten, PI – A feasibility study to evaluate the implementation of a post-hospitalization discharge review of device diagnostics and implementation of a treatment algorithm for the management of heart failure (HF) patients whose parameters have crossed a set threshold.

CONNECT

Medtronic – Brad Sodowick, PI – 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.

DECODE

Guidant – Bradford Sodowick, PI – 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.

MIRACLE EF

Medtronic, Inc. – Michael Rozengarten, PI – A prospective, randomized, controlled, double-blinded, global multi-center, Cardiac Resynchronization Therapy (CRT) in Heart Failure (HF) clinical study. The purpose of this study is to evaluate market released CRT pacemaker (CRT-P) devices in symptomatic HF patients with less severe left ventricular systolic dysfunction, specifically patients with reduced left ventricular ejection fraction (LVEF) in the range of 36% to 50%..

MULTISENSE

Boston Scientific – Michael Rozengarten, PI – The purpose of the MultiSENSE study is to collect chronic ambulatory data simultaneously from multiple sensors in CRT-D devices in order to develop algorithms for the early detection of worsening HF. The primary objectives of this study are to determine how ambulatory sensor measurements change with worsening HF, and to develop multisensor detection algorithms.

RAPID RF

Guidant – Bradford Sodowick, PI – 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.

RELY

Boehringer Ingelheim – Scott Burke, PI – 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)

SMART AV

Boston Scientific – Michael Rozengarten, PI – SMARTDELAY determined AV Optimization: A Comparison to Other AV Delay Methods Used in Cardiac Resynchronization Therapy (SMART-AV)

TACTIC – AF

St. Jude Medical – Scott Burke, PI – The purpose of this pilot study is to evaluate the feasibility of study design, address safety concerns and identify adverse events associated from subjects being taken off of anticoagulation (AC) therapy in a patient population with paroxysmal or persistent AF.