Treatment Trials

74 Clinical Trials for Various Conditions

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COMPLETED
Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial
Description

The primary objective of this study is to compare the incidence of rate control (defined as: HR \<110 beats/min or conversion to sinus rhythm) at 2 hours after medication administration between oral immediate release diltiazem and intravenous continuous infusion diltiazem.

COMPLETED
Atrial Fibrillation/Flutter Outcome Risk Determination
Description

It is our hypotheses that 1) readily available Emergency Department data can be utilized in an Atrial Fibrillation clinical prediction rule to identify those patients at low or high risk for adverse outcomes; 2) Assigned risk can be utilized to drive physician decision-making by identifying patients who do not require hospital admission (low risk) and patients needing hospitalization (high risk); and 3) a facile version of the AFPR will be easily incorporated into standard Emergency Department patient management systems and assist physicians with risk stratification of patients presenting with Atrial Fibrillation.

COMPLETED
Placebo Controlled Double-blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200 or 300 mg OD With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter
Description

Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

COMPLETED
Double Blind Placebo COntrolled Dose Ranging studY of the eFficacy and safEty of SSR149744c 300 or 600 mg for the Conversion of Atrial Fibrillation / fluttEr
Description

Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

RECRUITING
Study of JK07 in Patients with Chronic Heart Failure
Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure. There will be 2 cohorts in this study: Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%. Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.

RECRUITING
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Description

Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart. Objective: To identify and monitor the effects of BTKi on the heart. Eligibility: People aged 18 and older currently receiving or planning to receive BTKi or venetoclax. Design: Participants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit. Participants will undergo multiple tests: A physical exam, including collection of blood and saliva. A test that measures heart activity via stickers placed on the chest. A test that uses sound waves to capture images of the heart. An exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises. Stress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken. Participants may wear a device to monitor their heart at home. Participants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years. ...

ACTIVE_NOT_RECRUITING
Clinical Decision Support for Atrial Fibrillation and Flutter
Description

Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.

TERMINATED
Safety and Efficacy of Vanoxerine for the Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm
Description

LGN-VN-003 is a prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent onset atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm. Up to 625 subjects will be randomized in a 2:1 fashion so at least 400 vanoxerine and 200 placebo subjects receive study drug.

UNKNOWN
PREdicting Atrial Fibrillation or Flutter
Description

The purpose of this study is to determine, through continuous monitoring with a cardiac monitoring device placed under the skin, the incidence of atrial fibrillation or flutter (AF). The cardiac monitor will be placed in patients without symptoms but at risk for AF. It is hoped that this information may assist health care professionals in treatment decisions related to the early identification of patients at high risk for AF.

COMPLETED
Impact Of Different Ablation Approaches on Outcome In Coexistent Atrial Fibrillation and Flutter
Description

This prospective, multi-center, single blinded study aims to compare the influence of two different catheter ablation strategies, on long-term ablation outcome in terms of AF recurrence and quality of life (QoL) in patients presenting with coexistent AF and AFL. The two strategies to be evaluated are 1) the ablation of paroxysmal atrial fibrillation (PAF) with or without flutter (AFL) ablation (AF ± AFL) versus 2) AFL ablation alone.

COMPLETED
Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
Description

This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration

COMPLETED
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
Description

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

COMPLETED
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Male Subjects
Description

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in male patients.

COMPLETED
Intravenous Tedisamil in the Rapid Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm in Female Subjects
Description

The purpose of this study is to demonstrate the ability of tedisamil to convert atrial fibrillation or flutter into normal sinus rhythm (NSR) in female patients.

UNKNOWN
Dielectric Tissue Imaging in Cavotricuspid Isthmus Ablation
Description

This is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the KODEX - EPD functions for assessing tissue pressure, tissue thickness, lesion transmurality.

ACTIVE_NOT_RECRUITING
Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Description

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.

COMPLETED
Diltiazem in the Treatment of Atrial Fibrillation or Atrial Flutter With Rapid Ventricular Rate
Description

To compare the relative efficacy for calcium pre-treatment in decreasing incidence of drug induced hypotension after diltiazem administration for treatment of AFF with RVR. Null Hypothesis: There will be no difference between groups in incidence of hypotension after pretreatment with calcium prior to bolus of diltiazem.

COMPLETED
Electronic Alerts for Stroke Prevention in Patients With Atrial Fibrillation or Atrial Flutter
Description

Atrial fibrillation (AF) is the most preventable cause of stroke. CHADS and CHA2DS2VASc scores predict the likelihood of stroke in patients with nonvalvular AF. Atrial flutter confers a similar risk of stroke as atrial fibrillation. Anticoagulant therapy with warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban is effective for prevention of thromboembolic stroke in most patients with AF. However, despite widely available risk stratification tools, five options for anticoagulation, and evidence-based practice guidelines, thromboprophylaxis for stroke prevention in AF is under-prescribed in the U.S., Europe, and worldwide. The investigators have previously demonstrated the efficacy of an alert-based computerized decision support (CDS) strategy for prevention of symptomatic venous thromboembolism (VTE) in at-risk hospitalized patients not receiving any thromboprophylaxis. The investigators' goal is to create and evaluate an alert-based CDS strategy for stroke prevention in patients with nonvalvular AF or atrial flutter in a randomized controlled trial.

COMPLETED
Comparison of Diltiazem and Metoprolol in the Management of Acute Atrial Fibrillation or Atrial Flutter
Description

Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia encountered in the emergency department (ED) and the most common dysrhythmia treated by emergency physicians. Atrial flutter is less common than atrial fibrillation but its management in the ED is very similar, and the majority of patients with atrial flutter also have atrial fibrillation. Symptomatic relief and ventricular rate control are generally the primary therapeutic objectives in the ED management of acute atrial fibrillation and flutter (AFF). The need for swift, appropriate action by the emergency physician is highlighted by the fact that up to 18% of patients with AFF develop potentially life-threatening complications such as congestive heart failure, hypotension, ventricular ectopy, respiratory failure, angina and myocardial infarction. Both beta-blocking agents and calcium channel blockers are commonly used to treat AFF in the ED. Metoprolol is the most commonly used beta-blocker; and diltiazem is the most frequently used calcium channel antagonist.\[8\] Diltiazem was released by the FDA for treatment of AFF in 1992. Shreck et al. were the first to demonstrate both the efficacy of diltiazem in the ED management of AFF with rapid rate and its clear superiority over the previously most commonly used pharmacologic agent, digoxin. To date, only one prospective, randomized trial has compared the effectiveness of a calcium channel blocker (diltiazem) with a beta-blocker (metoprolol) for rate control of AFF in the ED. Despite the relatively small sample size (n=20 in each group) the authors concluded that both pharmacologic agents were similarly effective. In order to test this finding, the investigators conducted a prospective comparison of metoprolol and diltiazem for the management of patients presenting to the ED with AFF with rapid ventricular rate.

COMPLETED
American-Australian-African Trial With Dronedarone in Patients With Atrial Fibrillation or Atrial Flutter for the Maintenance of Sinus Rhythm
Description

To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL). To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence. To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

COMPLETED
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter
Description

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

COMPLETED
Multipolar Mapping and Atrial Arrhythmias
Description

This clinical investigation utilizes the Constellation Full Contact Mapping catheter in the left and right atria to explore atrial signal characteristics that can guide atrial fibrillation and atrial flutter ablation procedures more effectively.

COMPLETED
Propagation ANalysis for Arrhythmogenic Conduction Elimination to Prevent Atrial Flutter and Fibrillation (PANACEA-AF)
Description

The purpose of this study is to perform ultra-high density mapping of the left atrium (a chamber of the heart) using the the Rhythmia Mapping System and to determine whether additional ablation in areas of wavefront discontinuities identified by the map will reduce the likelihood of both atrial fibrillation and atrial flutter.

WITHDRAWN
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
Description

The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).

COMPLETED
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
Description

This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.

NOT_YET_RECRUITING
Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter
Description

The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.

ENROLLING_BY_INVITATION
ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression Study
Description

The (ADVENT LTO) is an observational, non-significant risk study to assess the progression of atrial fibrillation in subjects who received ablation treatment with either the FARAPULSE Pulsed Field Ablation System or thermal ablation in the ADVENT Trial.

RECRUITING
Get With the Guidelines Atrial Fibrillation Registry
Description

Get With The Guidelines-Atrial Fibrillation is designed to assist hospital care teams in consistently providing the latest evidence-based treatment for their AFib patients. At the same time, it offers a means of monitoring the quality of AFib care in U.S. hospitals and building a database for continued research and further quality improvement.

ENROLLING_BY_INVITATION
Storytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation
Description

The overall goal of this study is to evaluate the effectiveness of a previously developed storytelling intervention on anticoagulation (AC) initiation/persistence in African American and Black patients with atrial fibrillation/flutter. The investigators hope to gain knowledge that may help treat atrial fibrillation or flutter and lower stroke and adverse cardiovascular event risks for African American and Black patients by increasing the use of blood thinning medications known as anticoagulants.

ACTIVE_NOT_RECRUITING
RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.
Description

Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.