FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

2014-07-23 21:30:27 | BioPortfolio


The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with CRT-D device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-IEGM optimization methods).


- This is a prospective, double-blinded, multicenter, randomized study

- Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12 months post implant with follow-up visits at 3, 6, 9 and 12 months

- Patients will be randomized at enrollment to either Group 1 ("QuickOpt Group") or Group 2 ("Control Group").

- Group 1 - The patient's device is programmed to sequential BiV pacing mode with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits.

- Group 2 - The patient's device is programmed to either simultaneous or sequential BiV pacing mode as per physician's discretion. The AV/PV and VV delays could be programmed empirically or optimized using any non-IEGM based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post implant. Any AV/PV and VV delay optimizations performed after 4 weeks post implant in Group 2 patients will be considered protocol deviations.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Patient Has a Standard Indication for a CRT-D


Optimization of atrio-ventricular (AV/PV) and inter-ventricular (V-V) delays


Cedars Sinai Hospital
Los Angeles
United States




St. Jude Medical

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:30:27-0400

Clinical Trials [1869 Associated Clinical Trials listed on BioPortfolio]

A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft

The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or...

SAVEPACe - Search AV Extension and Managed Ventricular Pacing for Promoting Atrio-Ventricular Conduction

SAVE PACe is a large, prospective, single-blinded, randomized clinical trial with the main objective to study the effect of unnecessary right ventricular apical pacing on the clinical outc...

Acute and Cronic Evaluation of AV/PV and VV Delay IEGM Based Optimisation Algorithm-QuickSept Study

AtrioVentricular (AV) and InterVentricular (VV) delay optimization can improve ventricular function in Cardiac Resynchronization Therapy (CRT) and is usually performed by means of echocard...

CRT Improved Clinical Response UK Trial

The main objective of the CRICKET study is demonstrate that AV and VV optimization using SonR improves LV reverse remodeling response to CRT, compared with 'Fixed Settings' (FS) after 6 mo...

Effects of Echo-optimization of Left Ventricular Assist Devices on Functional Capacity (VAFRACT)

After the implantation of a left ventricular assist device (LVAD), many patients continue to experience exercise intolerance. LVAD echo guided optimization (EO) determines a more favorable...

PubMed Articles [17349 Associated PubMed Articles listed on BioPortfolio]

Typical AV nodal reentrant tachycardia with upper common pathway Wenkebach.

A 67-year-old lady underwent electrophysiologic testing because of recurrent palpitations. Atrio-His (AH) and His-ventricular intervals measure 98ms and 44ms, respectively. Retrograde conduction was m...

Unusual manifestation of left ventricular electrical conduction delay on the surface 12-lead electrocardiogram in a patient with prior myocardial infarction.

We describe a 41-year-old man with a prior history of myocardial infarction, whose surface 12-lead electrocardiogram did not show typical left bundle-branch block pattern or wide QRS complex. However,...

Ventricular Pseudoaneurysms after Perventricular Closure of Ventricular Septal Defect.

Perventricular ventricular septal defect closure has become an accepted method for treatment of some muscular and perimembranous ventricular septal defects. We report the case of a child who developed...

Regenerating a ventricular cavity during left ventricular assist device implantation.

Ten months after an ineffective percutaneous coronary stent placement, a 53-year-old patient was rehospitalized with NYHA functional class IV congestive heart failure, ischemic heart disease and left ...

Adaptive Cardiac Resynchronization Therapy is Associated with Decreased Risk of Incident Atrial Fibrillation Compared to Standard Biventricular Pacing: A Real-World Analysis of 37,450 Patients Followed by Remote Monitoring.

The AdaptivCRT algorithm (aCRT) automatically adjusts AV delays each minute to achieve ventricular fusion through left ventricular (LV) or biventricular (BiV) pacing. aCRT is associated with superior ...

Medical and Biotech [MESH] Definitions

A potentially lethal cardiac arrhythmia characterized by an extremely rapid, hemodynamically unstable ventricular tachycardia (150-300 beats/min) with a large oscillating sine-wave appearance. If untreated, ventricular flutter typically progresses to VENTRICULAR FIBRILLATION.

Isoforms of MYOSIN TYPE II, specifically found in the ventricular muscle of the HEART. Defects in the genes encoding ventricular myosins result in FAMILIAL HYPERTROPHIC CARDIOMYOPATHY.

An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation).

Cardiac electrical stimulators that apply brief high-voltage electroshocks to the HEART. These stimulators are used to restore normal rhythm and contractile function in hearts of patients who are experiencing VENTRICULAR FIBRILLATION or ventricular tachycardia (TACHYCARDIA, VENTRICULAR) that is not accompanied by a palpable PULSE. Some defibrillators may also be used to correct certain noncritical dysrhythmias (called synchronized defibrillation or CARDIOVERSION), using relatively low-level discharges synchronized to the patient's ECG waveform. (UMDNS, 2003)

A congenital cardiomyopathy that is characterized by infiltration of adipose and fibrous tissue into the RIGHT VENTRICLE wall and loss of myocardial cells. Primary injuries usually are at the free wall of right ventricular and right atria resulting in ventricular and supraventricular arrhythmias.

More From BioPortfolio on "FREEDOM - A Frequent Optimization Study Using the QuickOpt Method"

Quick Search


Searches Linking to this Trial