Treatment Trials

16 Clinical Trials for Various Conditions

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COMPLETED
Junctional AV Ablation in CRT-D: JAVA-CRT
Description

Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).

COMPLETED
Ivabradine for Rate Control in Permanent Atrial Fibrillation
Description

Ivabradine may be useful as a rate controlling agent in atrial fibrillation without negative effects on hemodynamics and inotropy. The objective in this proof of concept study is to investigate the hypothesis that ivabradine will slow the ventricular response in patients with permanent atrial fibrillation and previously-implanted pacemakers.

COMPLETED
Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation
Description

The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.

COMPLETED
Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation
Description

Objective: This prospective study aims to examine the outcome of atrial fibrillation (AF) ablation after permanent pulmonary vein antrum isolation or pulmonary vein antrum isolation plus left atrial posterior wall isolation is proven by a repeat procedure. The study will be conducted in patients with different types of AF: paroxysmal AF (PAF) and non-PAF (Persistent AF and Long Standing Persistent AF). Hypothesis: In addition to permanent pulmonary vein antrum isolation, proven isolation of left atrial posterior wall is associated with more freedom from atrial arrhythmia at long-term follow-up after atrial fibrillation ablation, especially in non-PAF patients.

TERMINATED
Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy
Description

Primary Objective: * Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors Secondary Objective: * Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

TERMINATED
The Effect of Low Intensity Exercise on Quality of Life and Hemodynamics in Patients With Permanent Atrial Fibrillation
Description

The purpose of this study is to 1) assess the effect of routine exercise on the quality of life of patients with permanent atrial fibrillation, and 2) assess the effect of exercise on cardio-hemodynamics in patients with atrial fibrillation.

COMPLETED
Concomitant Treatment of Permanent Atrial Fibrillation
Description

RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System

COMPLETED
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
Description

ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.

COMPLETED
Tailored Treatment of Permanent Atrial Fibrillation
Description

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

COMPLETED
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study
Description

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.

COMPLETED
Organization of Excitation in People With Atrial Fibrillation
Description

Atrial fibrillation (AF) is a condition in which the upper chambers of the heart, the atria, undergo an irregular beating rhythm. Despite the fact that AF is the most common type of sustained cardiac rhythm disturbance the investigators still do not understand it entirely and its current therapies are only marginally effective. The overall goal of our project is to determine the organization and mechanisms of electrical activation patterns during AF in humans.

UNKNOWN
Comparison of ATI-5923, a Novel Vitamin K Antagonist, With Warfarin in Patients Requiring Chronic Anticoagulation
Description

The purpose of this research study is to test an experimental drug ATI-5923 vs Coumadin. The study is intended to demonstrate ATI-5923 is superior to Coumadin for keeping INR values in the desired therapeutic range. Patients who require chronic anticoagulation with one or more of the following conditions are eligible for the study: atrial fibrillation or atrial flutter, prosthetic heart valve, venous thromboembolic disease, or history of myocardial infarction or cardiomyopathy will be enrolled.

TERMINATED
Effects of Dronedarone on Atrial Fibrillation Burden in Subjects With Permanent Pacemakers
Description

Primary objective was to evaluate the effects of dronedarone on Atrial Fibrillation (AF) burden (i.e. percent time in AF) as measured on electrogram (EGM) in subjects with a permanent pacemaker. Secondary objectives were to evaluate: * the effects of dronedarone on AF pattern characteristics i.e. ventricular rate during AF; * the effects of dronedarone on subject-perceived AF burden and symptom severity as reported by subjects using the Atrial Fibrillation Severity Scale (AFSS); * the incidence of electrical cardioversion (or overdrive pacing) during treatment; * the safety of dronedarone.

COMPLETED
Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation
Description

This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.

TERMINATED
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
Description

The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF). Many candidates of this device have a previously implanted cardiovascular implantable electronic device (CIED)- internal cardioverter defibrillator (ICD) or permanent pacemaker (PM). Patients with heart failure are at high risk for both atrial and ventricular cardiac arrhythmias. The aim of this study is to evaluate patients for Atrial fibrillation (AF) burden episode data obtained from interrogation of their CIED 8 months or greater after Optimizer implant and compare arrhythmia burden 6 months before Optimizer Cardiac Contractility Modulation (CCM) device insertion to 8 months or greater after Optimizer insertion (after 2 month blanking period).

COMPLETED
Assessing Arrhythmias After Ablation Using Implantable Recorders
Description

The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.