Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.

Learn more about:
Related Clinical Trial
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease CorCinch-HF Repair System in Patients Who Present With Symptomatic Non-Ischemic or Ischemic Dilated Cardiomyopathy Early Administration of Ivabradine in Children With Heart Failure Metabolomics and Microbiomics in Cardiovascular Diseases Mannheim TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies Risk Stratification in Children and Adolescents With Primary Cardiomyopathy Pediatric Cardiomyopathy Mutation Analysis German Centre for Cardiovascular Research Cardiomyopathy Register Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO An Integrative-“Omics” Study of Cardiomyopathy Patients for Diagnosis and Prognosis in China Metabolomic Study of All-age Cardiomyopathy Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry The Genetics of Cardiomyopathy and Heart Failure Inflammation, Cardiac Sympathetic Innervation, and Arrhythmic Sudden Death Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe Randomized Trial of Interventions to Improve Warfarin Adherence Testing Strategies to Improving Warfarin Adherence Prospective Study Looking at Quality of Life Measures in Non-ischaemic Cardiomyopathy After Mitral Valve Repair Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study The Cardiovascular Genetic and Therapeutic Implications of Muscular Dystrophy A Randomized Trial of Carvedilol in Chronic Chagas Cardiomyopathy Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF) Echo Assessment of Intraventricular Dyssynchrony Brain Function and Perfusion in Patients With Heart Failure Molecular and Imaging Studies of Cardiovascular Health and Disease Genotype-Phenotype Associations in Pediatric Cardiomyopathy (PCM GENES) Optimizing Left Ventricular Lead To Improve Cardiac Output Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia. Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-491 Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure ACC – Atrial Contribution to CRT Follow-up Safety Trial in Children With Chronic Heart Failure Therapy Receiving Orodispersible Minitablets of Enalapril Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie) Manganese-Enhanced Magnetic Resonance Imaging of the Myocardium Efficacy of Implantable Cardioverter Defibrillator in Patients With Non-ischemic Systolic Heart Failure on Mortality Cardiac Biomarkers in Pediatric Cardiomyopathy (PCM Biomarkers) Arrhythmia Prediction Trial Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants A Single Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of MYK-491 Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study. Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy Observational Trial of Cardiotoxicity in Patients Undergoing Chemotherapy. A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure Effect of Rosuvastatin on Left Ventricular Remodeling Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy Assessment of Right Ventricular Function in Advanced Heart Failure An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 Optimized Biventricular Pacing Allograft Recipients BiPAP for Cardiomyopathy With Central Sleep Apnea Relationship Between Abnormalities of Desmin Cytoskeleton, Mitochondrial Activity and Expression of Ubiquitin in Aspect of Pathogenesis of Heart Failure and Prognosis Effect of Aldosterone on Energy Starvation in Heart Failure Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside Therapy With Verapamil or Carvedilol in Chronic Heart Failure Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure Danish ICD Study in Patients With Dilated Cardiomyopathy Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy DCM Precision Medicine Study A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy A Trial of Autologous Bone Marrow Derived Stem Cells in Paediatric Heart Failure Resynchronization Therapy in Young Patients With and Without CHD Withdrawal of Medication in Recovered DCM Use of Bone Marrow Derived Stem Cell and G-CSF With Circulatory Assistance in the Treatment of DCM The Influence of Atorvastatin on the Parameters of Inflammation and the Function of Left Ventricle Safety and Feasibility of Algisyl-LVR™ as a Method of Left Ventricular Restoration in Patients With DCM Undergoing Open-heart Surgery PUFAs and Left Ventricular Function in Heart Failure 18F-deoxyglucose (FDG) PET-CMD Repetitive Intramyocardial CD34+ Cell Therapy in Dilated Cardiomyopathy (REMEDIUM) Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy Combination of Olmesartan Effect on Myocardial Viability of Patients With Dilated Cardiomyopathy Mesenchymal Stem Cells for Idiopathic Dilated Cardiomyopathy Continues Positive Airway Pressure Treatment for Patients With Dilated Cardiomyopathy and Obstructive Sleep Apnea Pathophysiology of Dilated Cardiomyopathy Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy Clinical and Genetic Examinations of Dilated Cardiomyopathy Simvastatin Therapy in Patients With Dilated Cardiomyopathy. Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy Safety and Efficacy Study of Intramyocardial Stem Cell Therapy in Patients With Dilated Cardiomyopathy Respiratory Muscles Training in Patients With Dilated Cardiomyopathy Myocardial Metabolism in Patients With Dilated Cardiomyopathy Intracoronary Autologous Mesenchymal Stem Cells Implantation in Patients With Ischemic Dilated Cardiomyopathy Orodispersible Minitablets of Enalapril in Children With Heart Failure Due to Dilated Cardiomyopathy Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy Cell Therapy In Dilated Cardiomyopathy Safety and Efficacy Study of Stem Cell Transplantation to Treat Dilated Cardiomyopathy Intracoronary Infusion of Autologous Bone Marrow Cells for Treatment of Idiopathic Dilated Cardiomyopathy Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure. Nesiritide – Dilated Cardiomyopathy A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy Defining the Role of Insulin Resistance in ‘Idiopathic’ Dilated Cardiomyopathy Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM) Use of Ixmyelocel-T (Formerly Catheter-based Cardiac Repair Cell [CRC]) Treatment in Patients With Heart Failure Due to Dilated Cardiomyopathy A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy Supramaximal Titrated Inhibition of RAAS in Dilated Cardiomyopathy Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy Honey in Idiopathic Dilated Cardiomyopathy A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy

Brief Title

Using Ripple Mapping to Guide Substrate Ablation of Scar Related Ventricular Tachycardia.

Official Title

Determining the Pathophysiological Role of Slow Conduction Channels Identified by Ripple Mapping of the Ventricular Scar.

Brief Summary

      The heart beat is controlled by electrical signals. Following a heart attack, part of the
      heart muscle dies and is later replaced by scar tissue. Within this area of scar, there often
      remain "channels" of surviving tissue still able to transmit electrical signals. However, it
      is well established that these "conduction channels" (CC) can form a short circuit around the
      scar, leading to electrical disturbances (arrhythmias) that are potentially life threatening.
      The commonest of these is ventricular tachycardia (VT), and is estimated to cause 300,000
      deaths per year.

      One recognised treatment option of VT involves burning (ablation) these "conduction channels"
      (CC) within the scar. However, at present, the procedure is long and is far off 100%
      effective. Consequently, current best practice does not rely on treating the VT, but rather
      preventing it from causing sudden death - this is achieved with an Implantable Cardioverter
      Defibrillator (ICD), a device which can recognise when a patient is in VT and deliver an
      internal shock to restore the normal electrical conduction. Patients with defibrillators
      subsequently are subject to recurrent painful and debilitating shocks which, although
      lifesaving, significantly reduce their quality of life. The limitation with ablation at
      present is due to the difficulty in visualising these CC's.

      Investigators at Imperial College have created a novel electrogram visualisation program,
      Ripple Mapping (RM), which they have already found to be superior to currently used
      programmes in cases of arrhythmias in the upper chambers of the heart (the atria). During a
      retrospective study in patients with scar related VT following a heart attack, when ablation
      was delivered in areas associated with identified Ripple Mapping Conduction Channels, these
      patients remained free of VT recurrence for >2 year follow up interval.

      The study hypothesis is that Ripple Mapping can identify all conduction channels within scar
      tissue critical to the VT circuit, ablation of which will lead to long-term freedom from VT
      and ICD therapies. The investigators now aim to perform a prospective randomised study
      comparing Ripple Mapping guided VT ablation against conventional VT ablation.
    

Detailed Description

      In patients with a previous heart attack, the scar formed in the left ventricle (bottom
      chamber of the heart) consists of dead tissue mixed with strands of live tissue which form
      "conduction channels" (CC's). These Conduction channels can cause dangerous heart rhythms
      such as Ventricular Tachycardia (VT). This can lead to symptoms such as shortness of breath,
      dizziness, blackouts, and, in some, sudden death.

      Patients at risk of sudden death receive special implanted devices called implantable
      cardioverter defibrillators (ICD) and can present with recurrent painful and debilitating ICD
      therapies consisting of internal shocks. Patients experiencing frequent ICD shocks due
      recurrent VT usually undergo a procedure to burn (ablate) the area of scar within the heart
      thought to be the source of the VT. This involves catheters (plastic tubes) inserted into the
      heart via the groin vessels allowing the cardiac electrophysiologists to obtain information
      about the scar. Scar tissue has low electrical voltage. By measuring the electrical voltage
      of the tissue in the heart, areas of scar as well as areas of live, healthy tissue can be
      identified and mapped. By burning (ablation) these abnormal channels of live tissue within
      scar (conduction channels), this can effectively reduce the episodes of VT a patient
      experiences, thereby reducing the frequency of shocks they experience and improve their
      quality of life.

      In any one patient, more than 1 conduction channel and hence source of VT can be found.
      Current mapping technologies are incapable of providing electrophysiologists with the
      information that is required to locate all these conduction channels. Therefore ablation
      strategies have shifted from ablating in a single location in the scar, to extensive ablation
      within the scar in the hope that ALL conduction channels will be burnt. However, this
      extensive ablation strategy has no globally agreed consensus with several techniques used
      worldwide.

      The disadvantage of this extensive ablation strategy is that the potential regions which can
      be responsible for VT can be large, requiring extensive ablation and therefore prolonged
      procedure times in sick patients who are unable to tolerate such lengthy procedures. In its
      current state, VT ablation by any strategy is technically challenging and time consuming with
      procedural times as long as 8 hours. In addition, although acute procedural success ranges
      from 77% to 95%, recurrence rates remain high - up to 50%.

      Therefore, identification of ALL conduction channels within scar is a desirable goal for
      catheter ablation therapy in VT. Ripple Mapping (RM) is a novel mapping program which allows
      simultaneous display of "voltage" and "activation" data of the underlying ventricular tissue.
      RM therefore has the potential to display more detailed information of the functional
      properties of the underlying scar including any interspersed live tissue channels.
      Investigators at Imperial College have demonstrated the proof of concept of RM and validated
      the program in a series of abnormal heart rhythms that arise within the upper heart chambers
      (the atria) where RM was found to have a superior diagnostic yield as well as aiding the
      operator in reaching a diagnosis in shorter time when compared with conventional mapping
      systems. The Investigators subsequently performed a retrospective analysis of 21 patients
      undergoing post infarct VT ablation. All documented locations with concealed entrainment or
      perfect pace matches to the induced or clinical VT coincided with Ripple Mapping Conduction
      Channels (RMCC). In patients where ablation lesions overlapped all identified RMCCs, these
      patients remained free of VT recurrence for >2 year follow up interval.

      The Investigators therefore propose to study the hypothesis that Ripple Mapping can identify
      all conduction channels within scar tissue critical to the VT circuit, ablation of which will
      lead to long-term freedom from VT and ICD therapies. This will be determined via a
      prospective randomised study comparing Ripple Mapping guided VT ablation against conventional
      VT ablation.
    


Study Type

Interventional


Primary Outcome

Time to first appropriate ICD therapy

Secondary Outcome

 Total appropriate ICD episodes

Condition

Monomorphic Ventricular Tachycardia

Intervention

Ripple Mapping guided VT ablation

Study Arms / Comparison Groups

 Ripple Mapping guided VT ablation
Description:  Ripple Mapping (Imperial College) software (Biosense Webster) will be used to identify conduction channels within the ventricular scar substrate to guide ablation lesions in patients with monomorphic VT.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

August 2014

Completion Date

August 2018

Primary Completion Date

August 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Evidence of VT (shock/ anti tachycardia pacing/ detection) on ICD (single, dual or
             bi-ventricular) interrogation or 12 lead ECG.

          2. Presumed scar related VT post myocardial infraction infarct/ dilated cardiomyopathy.

          3. Age range 18-85yrs.

          4. ICD implantation for primary or secondary prophylaxis, or device implantation
             pre-discharge from hospital post ablation procedure.

          5. Signed informed consent

        Exclusion Criteria:

          1. Contraindication to catheter ablation

          2. Coronary revascularisation required

          3. Ventricular tachycardia due to transient, reversible causes

          4. Presence of cardiac thrombus

          5. Severe cerebrovascular disease

          6. Active gastrointestinal disease

          7. Renal failure with creatinine >200 μmol/L or on dialysis

          8. Active fever or infection

          9. Life expectancy shorter than the trial

         10. Allergy to contrast

         11. Intractable heart failure (NYHA Class IV)

         12. Bleeding or clotting disorders or inability to receive heparin

         13. Pregnancy

         14. Must not have previous (4 weeks prior to screening) or current participation in
             another clinical trial with an investigational drug or investigational device

         15. Unable to give informed consent

         16. Unable to attend follow-up visits or ICD clinics
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Prapa Kanagaratnam, MBBChir PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02216760

Organization ID

14HH1922


Responsible Party

Sponsor

Study Sponsor

Imperial College London


Study Sponsor

Prapa Kanagaratnam, MBBChir PhD, Principal Investigator, Imperial College Healthcare NHS Trust


Verification Date

May 2019