Treatment Trials

34 Clinical Trials for Various Conditions

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COMPLETED
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
Description

The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.

UNKNOWN
Impact of the Pulmonary Vein Isolation on Exercise Capacity in Patients With Chronic Atrial Fibrillation
Description

This study would assess the impact of radio-frequency catheter ablation on exercise capacity and quality of life in long-standing persistent atrial fibrillation (LSP-AF) patients

COMPLETED
Modified Ablation Guided by Ibutilide Use in Chronic Atrial Fibrillation
Description

Procedures for ablation of persistent or long lasting atrial fibrillation are frequently long and require extensive ablation. Some electrophysiologists administer the drug ibutilide during these procedures to help organize the fibrillatory activity of the left atrium with the hope that this may shorten the length of the procedure and duration of ablation needed. Currently there is no standardized approach of administering the drug ibutilide during these procedures, thus the investigators cannot be certain that administering this drug does in fact facilitate the procedure. The aim of the MAGIC-AF Trial is to see if administering a standard dose of the drug ibutilide at a standard time in the procedure can allow for a reduction in the ablation procedure time. The investigators hypothesize that administering ibutilide during these procedures will result in a reduction in the procedure and ablation time required.

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.

RECRUITING
CONVERGE Post-Approval Study (PAS)
Description

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense ST™ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

UNKNOWN
Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
Description

Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation

RECRUITING
Atrial Fibrillation: Chronic Beta-blocker Use Versus As-needed Rate Control Guided by Implantable Cardiac Monitor
Description

The goal of this study is to test the feasibility of guiding as-needed pharmacological rate control of atrial fibrillation (AF) by implantable cardiac monitors and to assess the impact of continuous beta-blocker therapy versus as-needed rate control on the following outcomes: (1) exercise capacity, (2) AF burden, (3) symptomatic heart failure, (4) biomarker assessment of cardiac filling pressures and cardio-metabolic health, and (5) quality of life in patients with atrial fibrillation and stage II or III heart failure with preserved ejection fraction.

RECRUITING
Comparing Pulmonary Vein Isolation to Pulmonary Vein Isolation + OPTIMA Ablation in Patients Undergoing Ablation for Atrial Fibrillation
Description

Catheter ablation is an established cornerstone of therapy for patients with symptomatic atrial fibrillation (AF) who wish to avoid anti-arrhythmic drug therapy or for whom anti-arrhythmics have proven ineffective. Pulmonary vein isolation (PVI), in which circumferential ablation is performed around the ostia of the pulmonary vein - left atrial junctions, is the standard ablation approach internationally. Single-procedure success rates (1y, freedom from AF, off anti-arrhythmics) for patients with paroxysmal AF is roughly 70%, and even worse (roughly 50%) for patients with persistent AF. A number of strategies have been developed to improve outcomes in patients undergoing AF ablation, particularly in patients with persistent AF. Unfortunately, large prospective randomized trials (including STAR-AF II, published in NEJM in 2015) have demonstrated a failure of ancillary ablation techniques to improve AF ablation outcomes relative to PVI alone. In a collaborative effort between the Cardiology electrophysiology group and the Trayanova laboratory (Biomechanical Engineering), investigators have developed a strategy of patient-specific modeling to identify pro-arrhythmic sites in AF patients that may be amenable to ablation. In this approach, patients undergo a pre-ablation cardiac MRI with late gadolinium enhancement, to delineate regions of healthy atrial tissue and regions of scar (this scan is clinically indicated, and performed currently in patients undergoing PVI for AF). A novel in silico modeling to determine regions supporting electrical reentry in the atrium, driving ongoing AF, has been developed by the Trayanova lab. In preliminary studies, investigators have demonstrated the ability to identify and target these regions with catheter ablation in patients undergoing PVI. Investigators would like to conduct a prospective, randomized clinical trial in patients undergoing ablation for symptomatic persistent AF. All patients enrolled would undergo standard pre-procedure imaging (LGE-MRI) prior to the day of procedure. Investigators have developed methodology termed OPTIMA (OPtimal Target Identification via Modeling of Arrhythmogenesis) to determine, based on non-invasive patient-specific anatomic and tissue data from late gadolinium enhancement cardiac MRI (LGE-CMR) and simulation of cardiac electrical function, personalized ablation targets for persistent AF in patients with fibrotic remodeling.. Patients would be randomized to receiving PVI only versus PVI + OPTIMA ablation at the time of ablation. Patients would then be followed in standard clinical fashion at 3m, 6m, and 12m to assess for ablation efficacy and for procedural complications. Investigators postulate a 20% improvement in freedom from AF with PVI + OPTIMA ablation form 50% to 70% (compared to PVI alone), investigators anticipate that in 1:1 randomization, a sample size of 80 patients in each arm will yield a power calculation of 80% with an alpha of 0.05. Investigators anticipate that enrollment and 1y clinical follow-up for 160 patients (total) undergoing AF ablation will require a 4y timeline.

COMPLETED
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
Description

The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone. The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.

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%.

WITHDRAWN
Antiorbital Calcium in Chronic Conditions
Description

The purpose of this study is to determine the mechanistic effects of an ionic calcium supplement in adults with atrial fibrillation, osteoarthritis, and hypertension. The study aims to determine if ionic calcium supplementation affects quality of life, rate of biological aging, bone densitometry, and blood biomarkers of bone metabolism over a six month period compared to non-ionic calcium comparator supplement.

TERMINATED
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Description

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.

Conditions
COMPLETED
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
Description

The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.

COMPLETED
A Fib Clinic of the Future Using KardiaPro Platform for Chronic Care of Patients With AF After Ablation Procedure
Description

Pulmonary vein isolation is a widely used strategy for the treatment of patients with symptomatic atrial fibrillation. After successful pulmonary vein isolation (no atrial fibrillation on transtelephonic rhythm recordings for 3 months following ablation), heart rhythm is not routinely monitored. The goal of this study is to determine whether the Kardia Mobile device detects AF at a different rate compared to our standard of care. The study also hopes to understand how this Kardia Mobile device and Kardia Pro platform affect health care utilization and patient anxiety.

COMPLETED
Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock
Description

Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock.

COMPLETED
The Signal-averaged ElectrocArdiogram in Long Term Follow-up of Chronic CHagas Disease - RIO de Janeiro Cohort
Description

The study investigated 100 subjects, both genders, with chronic Chagas disease, confirmed by at least two distinct serological tests, and classified according to Los Andes classification in a long term follow-up aiming at identifying the predictive value of the signal-averaged electrocardiogram for cardiac death and ventricular tachycardia. All subjects admitted to the study were submitted to clinical history taking, physical examination, and noninvasive assessment, including blood pressure measurement, resting 12-lead surface electrocardiogram, 24h ambulatory electrocardiogram monitoring, M-Mode/two-dimensional echocardiogram, signal-averaged electrocardiogram in both time and frequency domains. Selected subjects were further submitted to treadmill stress test and coronary angiography to rule out coronary heart disease. Subjects were followed by non-investigational primary care assistance at three to six months scheduled clinical visits on an outpatients basis. Both noninvasive and invasive evaluation during follow-up were requested at discretion of primary evaluation. Adverse outcomes were ascertained by review of medical records and active contact to either study subjects or their relatives.

TERMINATED
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
Description

This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

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.

ENROLLING_BY_INVITATION
Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors
Description

Acalabrutinib and Zanabrutinib are highly effective drugs used to treat Chronic Lymphocytic Leukemia, but they are associated with high blood pressure and abnormal heart rhythms. SENTINEL is an observational study that will use wearable technology to monitor heart rhythm and blood pressures at home to better understand how frequently patients are experiencing high blood pressure and/or abnormal heart rhythms.

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. ...

RECRUITING
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
Description

This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.

UNKNOWN
Safety of Amiodarone and Ranolazine Together in Patients With Angina
Description

Ranolazine is an effective and remarkably safe agent for the treatment of patients with chronic stable angina, but its inhibition of voltage gated potassium channels and electrocardiogram (EKG) corrected QT (QTc) prolongation properties have lead many to question its safety when combined with antiarrhythmic drugs. The investigators have proposed a study to determine the safety of ranolazine in patients with chronic stable angina who also take amiodarone. And are conducting a prospective single-center randomized single-blinded placebo controlled trial to run out of our large cardiology practice setting at Cardiovascular Consultants of Nevada. The hypothesis is that there will be no difference in the ventricular arrhythmia burden. The primary outcome will be the measurement of ventricular arrhythmia episodes on serial holter monitor and other serially acquired recordings (such as electrocardiogram, pacemaker or implantable defibrillator (ICD) data, and stress test data) over a three month trial period.

COMPLETED
Rural Hospital-Level Care at Home for Acutely Ill Adults
Description

This study examines the implications of providing hospital-level care in rural homes.

UNKNOWN
Prediction of Patient Deterioration Using Machine Learning
Description

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict patient deterioration throughout a patient's admission. This algorithm was then validated in a validation cohort.

UNKNOWN
Prediction of 30-Day Readmission Using Machine Learning
Description

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict the likelihood of 30-day readmission throughout a patient's admission. This algorithm was then validated in a validation cohort.

UNKNOWN
Prediction of Expected Length of Hospital Stay Using Machine Learning
Description

This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient's admission. This algorithm was then validated in a validation cohort.

COMPLETED
Rural Home Hospital: Proof of Concept
Description

This study examines the implications of providing hospital-level care in rural homes.

COMPLETED
Remote Physician Care for Home Hospital Patients
Description

This study examines the implications of providing remote physician care to home hospitalized patients compared to usual home hospital care with in-person/in-home physician visits.

UNKNOWN
Home Hospital for Suddenly Ill Adults
Description

The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.