Treatment Trials

31 Clinical Trials for Various Conditions

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COMPLETED
Comparison of Bolus Dosing of Methohexital and Propofol in Elective Direct Current Cardioversion
Description

A randomized, open-blinded, prospective study to evaluate the timeliness and safety of direct current cardioversion (DCCV) when using methohexital when compared to the more often used propofol.

COMPLETED
Myocardial Injury Following Elective Direct Current Cardioversion for Atrial Arrhythmias
Description

Researchers are trying to determine if heart injury occurs in subjects who undergo direct current cardioversion.

Conditions
TERMINATED
Dual Versus Single Shock for Cardioversion of Atrial Fibrillation
Description

The investigators aim to investigate the immediate success rate (rate of termination of atrial fibrillation) of dual shock cardioversion compared with standard single shock cardioversion in patients with baseline characteristics adversely influencing successful cardioversion. Baseline characteristics known to reduce the success rate of single shock cardioversion include: increased body mass index (BMI), chronic obstructive pulmonary disease, sleep apnea, enlarged left atrium, longer duration of atrial fibrillation and use of amiodarone.

COMPLETED
The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
Description

This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

COMPLETED
Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)
Description

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that puts them at risk of developing clots in the heart. Those clots can travel in the blood circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and used to prevent clots forming in people with "AF". Other established blood thinners work by stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An example of this type is Warfarin (Coumadin). The good effects of all blood thinners are preventing clots, and they may also have bad effects of increasing the chance of bleeding. People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular rhythm, known medically as "cardioversion". When this is done, people are currently most commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

COMPLETED
Anticoagulation With Rivaroxaban in Cardioversion -The ARC Study
Description

The purpose of this study is to determine that a new drug called "Rivaroxaban®" is effective in preventing patients from forming clots after their heart rhythm has been reset by the cardiologist with an electrical device.

COMPLETED
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
Description

A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

COMPLETED
QT Variability Pre and Post Cardioversion
Description

The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.

COMPLETED
Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)
Description

SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm. HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.

COMPLETED
Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study
Description

This is a sequential phase 1 and phase 2 study to evaluate the efficacy of intracardiac echocardiography to detect septal and left atrial pathology as compared to transesophageal echocardiography (Phase 1) and its value in a management strategy for immediate cardioversion during cardiac catheterization procedures in patients with atrial fibrillation as compared to a conventional strategy delaying cardioversion till full anticoagulation is established for a three weeks (Phase 2). Phase 1 will enroll 100 patients at 12 centers; these patients will be undergoing clinically indicated TEE \& cardiac catheterization procedures. After review of Phase 1 results by an independent DSMB \& the investigators that establish efficacy of ICE, Phase 2 will be initiated. Phase 2 will enroll 300 patients in 15 centers; these patients with atrial fibrillation will be undergoing clinically indicated cardiac catheterization procedures and have a clinical indication for cardioversion. Patients will be randomized to ICE guided cardioversion strategy or a conventional strategy employing three weeks of full anticoagulation before cardioversion. ICE imaging will be used to identify a low risk group for immediate cardioversion. A composite primary study endpoint that will include mortality and major morbidity including stroke and bleeding complications will be used. This study will examines two hypotheses in AF patients undergoing invasive cardiac procedures: Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of left atrial pathology or septal defects that can predispose patients to stroke. This will be evaluated during the Phase I component of the study. Hypothesis 2: That ICE can identify low risk patients in whom immediate cardioversion during the procedure is safe and comparably effective to electrical cardioversion performed based on a conventional strategy of a minimum of 3 weeks of preceding anticoagulation therapy. Low risk patients are expected to have an acceptably low incidence rate of stroke, transient ischemic attack (TIA), peripheral embolism, and major hemorrhagic events following electrical cardioversion. This will be evaluated during the Phase II component of the study, after the Phase I objective is achieved.

COMPLETED
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
Description

The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks

TERMINATED
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients with recent-onset, symptomatic newly diagnosed or paroxysmal AF. Approximately 400 patients are expected to be enrolled in this study. Patients will be randomized 3:1 to receive FlecIH-103 at a total dose of up to 120 mg estimated total lung dose (eTLD) (n=300) or placebo inhalation solution (n=100). Randomization will be stratified by geographic region (US and ex-US) and duration of symptoms of the current AF episode (≥1 hour to ≤24 hours and \>24 hours to ≤48 hours).

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
Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
Description

The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It will see if edoxaban prevents stroke and other blood clotting problems as well and as safely as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join. Their doctors must plan to use shock to make their hearts beat normally. About 2200 people from different countries will join. They will have an equal chance of receiving either treatment. They are anticipated to be in the study for around 82 days. Tests will include physicals and finger-pricks. Participants will provide blood and urine samples.

COMPLETED
Intravenous Magnesium Infusion in Patients Undergoing Cardioversion of Atrial Fibrillation Trial
Description

The proposed study is designed to evaluate the effect of an intravenous infusion of magnesium sulfate in facilitating successful cardioversion of atrial fibrillation and in decreasing the energy threshold (in J) required for successful cardioversion of atrial fibrillation into sinus rhythm.

TERMINATED
Combined Amiodarone and Electrical Cardioversion for Postoperative Atrial Fibrillation After Cardiac Surgery
Description

To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation

Conditions
TERMINATED
Ranolazine for the Prevention of Atrial Fibrillation After Electrical Cardioversion
Description

The investigators hypothesize that ranolazine would decrease the incidence of recurrence of Atrial Fibrillation (AF) after electrical cardioversion of persistent AF. Patients with persistent AF who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.

COMPLETED
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation
Description

The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of inflammation. Recently a high CRP level (indicating an increase in inflammation) was identified as a risk factor for atrial fibrillation. We are conducting this study with patients such as yourself with atrial fibrillation who are planning to undergo cardioversion to determine what sort of relationship exists between CRP levels and atrial fibrillation. We will then look at success rates of converting atrial fibrillation to normal sinus rhythm, compared to patients' CRP levels.

TERMINATED
The Use of DIOVAN to Reduce Post-Cardioversion Recurrence of Atrial Fibrillation Trial (the DRAFT Trial)
Description

24 week, single center, prospective, randomized, double-blind treatment study of valsartan (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to restore normal sinus rhythm (SR).

COMPLETED
Heart Watch Study: a Pragmatic Randomized Controlled Trial
Description

This will be a prospective multi-center, randomized, controlled trial of 150 patients conducted to assess the impact of individual use of the Apple Watch compared to the Withings Move on patient-reported and clinical outcomes at 6 months and up to 1 year.

ACTIVE_NOT_RECRUITING
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Description

This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF). Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be powered to show a difference between HBI-3000 and placebo in conversion rate at each of the two dose levels.

UNKNOWN
Atrial Fibrillation Detection Using Garmin Wearable Technology
Description

The purpose of this study is to evaluate the feasibility of detecting atrial fibrillation (AF) in patients with AF using a wearable wrist device/smart watch.

TERMINATED
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
Description

The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.

UNKNOWN
Detection of Left Atrial Appendage (LAA) Thrombus: Comparison of Cardiac Magnetic Resonance Imaging and Transesophageal Echocardiogram
Description

The purpose of this study is to compare Cardiac Magnetic Resonance (CMR) Imaging with transesophageal echocardiography (TEE) in detecting the presence of LAA thrombi in men and women with atrial fibrillation presenting for cardioversion.

COMPLETED
Radiofrequency Catheter Ablation for Chronic Atrial Fibrillation
Description

The purpose of this study is to determine the long-term efficacy of radiofrequency catheter ablation in patients with chronic atrial fibrillation.

TERMINATED
A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HSY244 in Participants With Atrial Fibrillation
Description

This was a randomized, placebo-controlled, investigator- and participant-blinded study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of HSY244 in participants with atrial fibrillation (AF), with and without heart failure (HF).

UNKNOWN
Rapid Atrial Fibrillation Treatment Strategy
Description

Prospective, randomized, open-label clinical trial studying the treatment of new onset atrial fibrillation in critically ill patients with septic shock. Patients will be assigned to rhythm vs rate control strategies with various outcome measures assessed.

COMPLETED
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Description

This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.

COMPLETED
Vest Prevention of Early Sudden Death Trial and VEST Registry
Description

This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.

COMPLETED
Atrial Electromechanical Interval and Pulse Wave Velocity in the Prediction of Recurrence of Atrial Fibrillation
Description

This study aims to evaluate the utility of the atrial electromechanical interval and pulse wave velocity in the prediction of recurrence of atrial fibrillation among patients who underwent successful direct current cardioversion for atrial fibrillation.