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59 active trials for Ventricular Tachycardia

SD01 Master Study (Safety and Efficacy Study)

The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

Start: May 2013

SD01 Registry (SD01 ICD Lead)

This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.

Start: March 2014

SMART Identification of Ventricular Tachycardia Isthmus

Context : Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps. The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive. The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method. Hypothesis : The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.

Start: April 2018

Catheter Ablation of Ventricular Arrhythmia Reduces Skin Sympathetic Activity

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.

Start: June 2021

South Asian Arrhythmogenic Cardiomyopathy Registry

Arrhythmogenic Cardiomyopathy (ACM) is increasingly identified as an important cause of cardiac morbidity and mortality, especially of SCD, in a younger population. Although there are no epidemiological data available, the investigators' experience is that in the North Indian region, ACM is rare outside our regions. ACM is also an understudied cardiac disorder in the South-Asian region. An ethnic nonmigratory population inhabits the two regions, and consanguineous marriages are common. Based on these observations, the investigators firmly believe that there may be a founder gene in our populations responsible for the increased incidence of ACM. Our project includes a thorough phenotypic analysis ((ECG, Holter, and echocardiography) in the ACM patients and their first-degree relatives; cardiac MRI and high resolution endocardial bipolar and unipolar voltage mapping (using HD grid catheter) in the patients. The patient provided blood for the extraction of DNA will first undergo target panel sequencing for 20 known classic right-dominant ACM and left-dominant ACM. If this is negative for known pathogenic and likely pathogenic variants but identified novel variants of uncertain significance (VUS), then co-segregation analysis in family members will be performed. This technique can provide helpful information to reclassify VUSs. If both these are negative, then whole-exome 'trio' analysis will be performed, whch includes the proband and two family members, to triangulate from all 20,000 genes to a list of candidates for further interrogation. The investigators wish to provide comprehensive answers to the research question by combining the genetic analysis with phenotypic evaluation.

Start: April 2021

Physiologic Pacing Registry

The Physiologic Pacing Registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

Start: November 2018

Noninvasive Cardiac Radioablation for Ventricular Tachycardia Refractory to Medication and Catheter Ablation

The purpose of this study is to evaluate the safety and efficacy of cardiac radioablation (CRA) as a means of noninvasive treatment of ventricular tachycardia (VT) refractory to both medication and catheter ablation.

Start: June 2021

A Clinical Trial Utilizing Dantrolene in Patients With Ventricular Arrhythmias.

This is a randomized, placebo controlled trial of Dantrolene (N= 84 participants) to demonstrate the feasibility of using I.V. dantrolene to study the effect of RyR2 inhibition on cardiac electrophysiology, hemodynamics and ventricular arrhythmia inducibility in patients with structural heart disease referred for VT ablation. The investigators will also explore the pharmacokinetic/pharmacodynamic relationship of I.V. dantrolene and it short-term effect on specific cardiac electrophysiologic and hemodynamic parameters.

Start: August 2020

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of iATP-capable devices. The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform (NCT01524276).

Start: August 2020

Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia

The purpose of the study is to assess the effectiveness and safety of a new device called an Intramural Needle Ablation Catheter (INA catheter). The INA catheter is used for locating and ablating ventricular arrhythmias that have failed standard radiofrequency ablation. This approach is desirable because some people have ventricular arrhythmias that originate deep within the heart muscle where it is not abolished by ablation with standard catheters. The investigators seek to determine whether the INA catheter can potentially help people who have ventricular arrhythmias that have failed standard radiofrequency ablation. The investigators also want to determine if it is likely to be safe, without excessive side effects.

Start: September 2016

Percutaneous Inferior Cervical Sympathetic Block for Treatment of Refractory Ventricular Tachycardia

The purpose of this research study is to examine the effect of percutaneous inferior cervical sympathetic block on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death.

Start: June 2021

Mayo AVC Registry and Biobank

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death. The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples. Objectives of the study: Discover new genes or altered genes (variants) which cause AVC Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation) Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies

Start: January 2016

IVTCC 2.0: A Prospective Multicenter Ventricular Tachycardia Catheter Ablation Registry

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.

Start: December 2018

Initial Management of Patients Receiving a Single Shock (IMPRESS)

The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD). All participants in this study will be fitted with a special electrode vest to detect the origin of heart rhythm abnormalities and then they will undergo a procedure called Non-Invasive Programmed Stimulation (NIPS). This procedure involves sedating a participants with anesthesia and then using the participant's own ICD to try to stimulate the heart to go into ventricular tachycardia. If this procedure is unable to induce the participant into ventricular tachycardia, then the participant will just be managed with usual care and will not be placed on any additional medications and will not undergo an ablation. However, if the NIPS induces the ventricular tachycardia, the electrode vest will be used to determine the origin of the abnormal heart rhythm inside the heart. After a successful NIPS procedure, the participants will be randomly assigned to either be placed on medication therapy or undergo catheter ablation. The outcomes from all three groups will be compared and the researchers hope to better understand which participants are most likely to benefit from watchful waiting versus medication versus catheter ablation.

Start: April 2018

Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

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.

Start: May 2021

Cardiac Rehab Retrospective Review (CR3)

All patients enrolled in the Austrian LifeVest Registry will be retrospectively screened for successfully completed ambulatory or stationary rehabilitation program. Baseline characteristics, complete rehab data, outcomes and follow up data, as well as wearable cardioverter defibrillator(WCD)-derived data will be collected from these patients. Specifically, performance data from the start of the exercise training (ET) will be compared to the end of ET; including type of training, exertion, time and duration will be collected. In addition, WCD recorded data such as automatically and manually recorded ECGs, compliance, and TRENDS data will be collected.

Start: February 2021

PASO Automated Template Matching for PVC Ablation

Pacemapping is an essential tool during ablation of idiopathic PVC and VT. Automated template matching has been shown to have a significant influence on PVC ablation procedures, but the PASO module of CARTO3 has not been studied in a randomized trial. The Aim of this study is to evaluate the additional benefit of PASO template matching on PVC ablation procedure with regard to procedural parameters and outcome when compared with conventional pace mapping. A total of 144 pts will be randomised in a 1:1 fashion to PVC ablation guided by conventional pacemapping vs PVC ablation guided by PASO pacemapping. Patients will be follow up with Holter-ECG and TTE after 3 and 12 months.

Start: February 2018

Ripple Mapping Guided Ablation of Ischaemic Ventricular Tachycardia.

The Ripple VT-1 Study is a prospective clinical trial that aims to investigate if catheter ablation of ventricular tachycardia in patients with ischaemic heart disease can be effectively performed using Ripple Mapping.

Start: April 2019

Prognosis Impact of NSVTs After an AMI (TeVeO Study).

Nowadays, Sudden Cardiac Death (SCD) due to malignant arrhythmias is an important cause of death among acute myocardial infarction (AMI) survivors. Preventive strategies with implantable cardioverter-defibrillators (ICD) are the best clinical option for patients, but associated sociosanitary impact in the National Health Systems and the fact that current implant strategy not always results in benefits for the patient requires to develop further selection criteria. The TeVeO project aims to study the events that take place early following an AMI to predict the short- and long-term risk of experiencing a potentially lethal ventricular tachycardia (VT). The project will carry out an observational and multicentric study involving 5 different hospitals to: a) qualitative and quantitative characterize non-sustained VTs (NSVT) that take place during the first 6 months after an AMI and b) characterize the evolution of the substrate (scar and surrounding tissue) in patients meeting criteria for ICD implant. Patients included in the study will be implanted with an implantable loop recorder (ILR) in order to register NSVT and cMRI images will be acquired prior to hospital discharge and at 6 months after AMI to study the substrate. Further patients' management will follow the protocols within each entity. Project results will allow us to stratify patients according to identified risks for developing malignant VT, which will improve patient selection for ICD implantation and will contribute to tailor patients' treatment and prevention, improving the cost-effectiveness of these devices and minimizing their associated problems and sociosanitary burden.

Start: August 2020

Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed

Start: March 2021