Treatment Trials

86 Clinical Trials for Various Conditions

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TERMINATED
Effects of Fish Oil on Post Ablation Arrhythmias
Description

To determine if peri-operative treatment with omega-3 fatty acids is associated with a decrease in the incidence of early recurrences of atrial arrhythmias (within 30 days) and an improvement in probability of long-term maintenance of sinus rhythm after radiofrequency catheter ablation for Atrial Fibrillation.

WITHDRAWN
Ventricular Arrhythmia Ablation With the Use of Non-Invasive ECG Imaging Technology
Description

Researchers are trying to determine if the use of software called VIVO, made by Catheter Precision, Inc. can shorten the length of time it takes to perform an ablation procedure for either premature ventricular contractions (PVCs) and ventricular tachycardia (VT).

SUSPENDED
Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
Description

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

TERMINATED
Catheter Ablation of Arrhythmias to Improve CRT Response
Description

The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.

COMPLETED
MRI Assessment of Arrythmia Ablation Lesions
Description

This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques. The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.

COMPLETED
CyberHeart's Cardiac Arrhythmia Ablation Treatment: Patients With Refractory Ventricular Tachycardia/Fibrillation
Description

The objective of this clinical investigation is to evaluate: 1. the safety and efficacy of the CyberHeart System, CardioPlan™ Software and Laptop, in treating patients with refractory ventricular tachycardia (VT) using the CyberKnife® Radiosurgical System. 2. The CyberHeart System performance with respect to the ability to contour myocardial targets that are transferred to the Multi-plan® Treatment Planning Software of the CyberKnife® system for the production and delivery of a safe radiosurgical treatment plan. Cardiac radiosurgery is a minimally-non invasive, painless, procedure. Tissue ablation can be accomplished precisely.

TERMINATED
AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
Description

AcQMap Registry is an observation study

RECRUITING
Insertable Cardiac Monitor-Guided Early Intervention to Reduce Atrial Fibrillation Burden Following Catheter Ablation
Description

To prospectively investigate the efficacy of an insertable cardiac monitor-guided atrial fibrillation (AF) management in reducing subsequent AF burden in patients with persistent or paroxysmal AF undergoing atrial catheter ablation (CA).

RECRUITING
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
Description

To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery

TERMINATED
Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity
Description

This study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. In addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.

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.

TERMINATED
Second Study to Assess Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Long Standing Persistent Atrial Fibrillation
Description

Pulmonary vein isolation (PVI) combined with empiric ablation of either common sites of non-PV triggers of Atrial Fibrillation (AF) and locations that may sustain stable AF sources should be more efficacious than PVI combined with ablation of only documented non-PV triggers of AF in achieving long-term arrhythmia control in patients with persistent or long standing persistent AF.

COMPLETED
Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias
Description

This study will examine the safety and efficacy of intramural needle ablation (INA) in the treatment of intramural ventricular arrhythmias in patients for whom standard RF ablation has been unsuccessful. The clinical team hypothesize that the increased current density and improved rates of transmural lesion creation seen with intramural needle ablation will lead to successful arrhythmia termination with minimal or no increased risk of complication.

ENROLLING_BY_INVITATION
Computational Cardiac Imaging Analysis to Guide Ventricular Tachycardia Ablation Procedures (AI-VT)
Description

The purpose of this study is to evaluate the clinical outcomes (clinical efficacy and safety) of using supplemental non-invasive computational ECG and cardiac imaging analysis tools to help guide ablation of ventricular tachycardia.

NOT_YET_RECRUITING
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Description

Background: Ventricular arrhythmia is an abnormal pulse rhythm that starts in the lower part of the heart (ventricles). Treatment includes ablation; ablation uses heat to destroy small portions of the heart that are causing short circuits in the normal heartbeats. But ablation does not always work well because some parts of the heart are hard to reach with current tools. Researchers want to try a new method called VINTAGE (ventricular intramyocardial navigation for tachycardia ablation guided by electrograms). VINTAGE may be better able to treat portions of the heart that are harder to reach with standard techniques. Objective: To test VINTAGE in people with ventricular arrhythmia. Eligibility: People aged 21 years and older with ventricular arrhythmia that did not respond to standard treatment. Design: Participants will have baseline tests. They will have blood tests and tests of their heart function. They will have imaging scans. They will complete a health questionnaire. Participants will undergo the VINTAGE procedure. They will be either completely or partially asleep. Doctors will insert tubes through large blood vessels in the groin. Tubes may also be inserted through the chest and wrist. They will use x-rays and ultrasound to guide tubes and guidewires directly into the heart muscle to do the ablation. Participants will stay in the hospital 1 or more nights after the procedure. Participants will have 3 follow-up visits over 6 months. These visits are for standard care after heart ablation. They will include blood tests, imaging scans, and tests of heart function. Participants may also wear a device to monitor their heart rhythms at home.

RECRUITING
Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
Description

The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures

RECRUITING
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Description

The purpose of this study is to examine the use of a point ablation catheter (Farapoint, Boston Scientific) in the mapping and ablation of focal ventricular arrhythmias (premature ventricular contractions or ventricular tachycardia) using pulsed field energy.

RECRUITING
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Description

Sphere-9 VT is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia due to prior myocardial infarction will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.

ENROLLING_BY_INVITATION
Ablation Guided Via Precision Imaging Using Electromechanical Wave Imaging
Description

Atrial and ventricular cardiac arrhythmias are serious public health problems in the United States, affecting over 5% of Americans and are major causes of stroke and heart failure leading to increased morbidity and mortality. This proposed clinical trial will determine how electromechanical wave imaging (EWI), a non-invasive ultrasound precision imaging modality, can effectively diagnose and determine the mechanism of the arrhythmia and impact personalized treatment of cardiac arrhythmias. Participants who are already scheduled for electrophysiology study will receive EWI prior to their study. Half of participants will randomly have their EWI imaging data available for their electrophysiologist to analyze and potentially affect procedure planning and execution. Across all participants the results of EWI and the electrophysiology study will be compared to determine EWI accuracy at diagnosing arrhythmias. Participants whose electrophysiologists had access to EWI data will be compared against those without access to determine if EWI data led to improved procedure efficiency and outcomes.

NOT_YET_RECRUITING
Ablation-Index Guided Ventricular Tachycardia Ablations
Description

Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA). Due to the challenging nature of visualizing lesion formation in real time and ensuring an effective transmural lesion, different surrogate measures of lesion quality have been used. The Ablation Index (AI) is a variable incorporating power delivery in its formula and combining it with CF and time in a weighted equation which aims at allowing for a more precise estimation of lesion depth and quality when ablating VAs. AI guidance has previously been shown to improve outcomes in atrial and ventricular ablation in patients with premature ventricular complexes (PVC). However research on outcomes following AI-guidance for VT ablation specifically in patients with structural disease and prior myocardial infarction remains sparse. We aim at conducting a prospective observational multicenter registry investigating the efficacy and safety of AI-guided VA ablation in patient with ischemic and non-ischemic cardiomyopathy.

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.

COMPLETED
AF-FLOW Registry to Evaluate Electrographic Flow Mapping in Patients Undergoing Ablation for Atrial Fibrillation
Description

This post-market global registry will evaluate the ability of Electrographic Flow (EGF™) mapping to identify atrial fibrillation (AF) sources and guide ablation therapy in patients with atrial fibrillation in real-world setting.

ACTIVE_NOT_RECRUITING
A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
Description

To acquire, amplify, digitize, and record atrial intracardiac electrophysiology signals during cardiac electrophysiology studies for the treatment of persistent atrial fibrillation and to use the recorded data to test the performance of an signal complexity visualization algorithm.

RECRUITING
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Description

The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.

ENROLLING_BY_INVITATION
IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry
Description

This is a prospective multi-center international registry. The objective of this registry is to collect prospective data on patients undergoing catheter ablation for Ventricular Tachycardia (VT) and Premature Ventricular Contractions (PVC). The registry will be used for clinical monitoring, research, and quality improvement purposes.

WITHDRAWN
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
Description

This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.

COMPLETED
Proton Particle Therapy for Cardiac Arrhythmia
Description

Researchers are gathering information on the safety and effectiveness of proton radiation therapy in reducing the number of ventricular tachycardia (VT) episodes in subjects who continue to experience VT despite treatment with an implantable cardioverter defibrillator (ICD) and undergoing a previous catheter ablation.

COMPLETED
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation
Description

Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.

COMPLETED
Hemodynamics Measurement in Radiofrequency Catheter Ablation
Description

This study will occur in patients undergoing routine cardiac ablation of his/her arrhythmia with planned use of an irrigated ablation catheter. The main objective of this study is to take intracardiac pressure measurements and pressure waveforms with both a "gold standard" balloon tipped pulmonary artery catheter placed for this study and an irrigated ablation catheter placed as standard of care for the procedure.

COMPLETED
Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation
Description

This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).