Ablation Therapy Clinical Trials - Mayo Clinic Research (2022)

  • Ventricular Arrhythmias and Premature Ventricular Contraction in Patients with Prosthetic Valve: Electrophysiological Characteristics, Ablation Technique, Outcomes And Complications Rochester, MN

    The purpose of this studyis to examinecharacteristic (electrophysiological) of ventricular arrhythmias, ablation technique and outcomes inpatients with prosthetic valve.

  • Efficacy of Delayed Enhancement MRI-Guided Ablation vs Conventional Catheter Ablation of Atrial Fibrillation Rochester, MN

    This proposal is aiming at modifying and improving persistent AF management guidelines by evaluating targeting DE-MRI detected atrial fibrosis during AF ablation and its related effect on procedural outcome.

    OBJECTIVES:

    Primary Objective: To examine the efficacy of targeting atrial fibrosis tissue during an ablation procedure in treating persistent AF. Results from the DECAAF study show that one of the most important predictors of ablation outcome was the degree of ablation of the fibrotic tissue; the more fibrotic tissue that was overlapped with scar during ablation, the better the outcome. These results were the impetus for the primary outcome ...

  • Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation Rochester, MN

    The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

  • ETHANOL ABLATION FOR TREATING CYSTIC THYROID NODULES Rochester, MN

    We want to determine the efficacy and safety, and the rate and type of side effects of this technique; as well as to delineate the clinical pathologic outcomes of the patients with thyroid cysts treated with Percutaneous ethanol injection (PEI) at Mayo Clinic, Rochester MN, since there is limited information of the use of this technique in the American literature.

  • A Study to Evaluate the Adagio System to Treat Persistent Atrial Fibrillation Jacksonville, FL

    The purpose of this study is to provide safety and effectivenessdata regarding the use of the Adagio System in the treatment of Persistent Atrial Fibrillation (PsAF).

  • Comparison of Short and Long-Term Outcomes between Surgical Septal Myectomy and Alcohol Septal Ablation Rochester, MN

    The standard of care for obstructive hypertrophic cardiomyopathy (HCM) refractory to medical therapy is surgical septal myectomy. Percutaneous transluminal septal myocardial ablation, otherwise known today as alcohol septal ablation (ASA) has been growing as a favorable alternative to myectomy. There have been no randomized controlled trials conducted to evaluate ASA versus surgical myectomy. The purpose of this study is to compare overall survival between surgical septal myectomy and alcohol septal ablation. The study will also compare periprocedural and long-term complication rates for both myectomy and alcohol septal ablation. Furthermore, the study willl determine the rates of re-intervention for both myectomy ...

  • Betrnet Stem Cells and the Origins of Barrett's Esophagus Project 3 RF Ablation Jacksonville, FL

    The purpose of this study is to determine biomarkers which can predict response to ablation therapy in patients with Barretts esophagus.

  • A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy Rochester, MN

    The purpose of this study is todetermine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.

  • Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II Scottsdale/Phoenix, AZ

    Single-arm, interventional pivotal clinical trial collecting patient data from use of the AQUABEAM System, a personalized image-guided waterjet resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).The primary endpoints for safety and effectiveness will be measured at 3 months post-treatment. All treated subjects will be followed out to 12 months to collect long-term clinical data.

  • The Effect of Ablation of Epidermal Nerve Fibers Using Capsaicin Cream Rochester, MN

    This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."

    Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.

  • The STAR Tumor Ablation Registry Rochester, MN

    The purpose of this registry is to collect clinical safety and outcomesdata on the use of the STAR™ Tumor Ablation System on patients with painful cancer matastases of their thoracic or lumbar spine.

  • MR-Guided Laser Ablation of Hepatic Tumors Rochester, MN

    This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

  • Stereotactic Laser Ablation for Temporal Lobe Epilepsy Rochester, MN

    The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser ablation system for mesial temporal epilepsy (MTLE).

  • A Study of MR-Guided Laser Ablation of Prostate Bed Recurrences Rochester, MN

    The purpose of this study is to see if MR-guided laser ablation can effectively treat prostate tumor recurrences.

  • Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) (NO FEAR-BE) Rochester, MN

    The purpose of thismulticenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication="" of="" barrett's="" esophagus="" (be)="" after="" 2="" rfa="">50%>

  • Pain Severity and Pain Interference Outcomes following Percutaneous MRI-Guided Laser Ablation and Cryoablation of Painful Peripheral, Soft Tissue Vascular Anomali Rochester, MN

    The purpose of this study is to determine ifMRI-guided laser ablation and cryoablation result in significant improvements in both pain severity and pain interference measures at intermediate-term follow-up in patients with painful, soft-tissue vascular anomalies.The study will also test the hypothesis that immediate loss of intrinsic vascular anomaly T2 signal is an imaging biomarker to predict decreased pain and VA volume following MRI-guided laser ablation and cryoablation in patients with painful, soft-tissue vascular anomalies.

  • A Study of the FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study Rochester, MN

    The purpose of this study isto demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

  • Evaluation of the Phased Radio Frequency Ablation System No Locations

    VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.

  • Clinical Trial Using the C2 Cryoballoon™ - for the Treatment of Non-Dysplastic, Low Grade Dysplastic or Indefinite for Dysplasia Barrett’s Esophagus No Locations

    The primary objective is to determine the safety of the C2 CryoBalloon Full Ablation System (“CryoBalloon Full”) used at increasing doses in subjects with non-dysplastic, Low-Grade Dysplastic (LGD) or indefinite for dysplasia Barrett’s Epithelium (BE).

    A secondary objective is to evaluate CryoBalloon Full efficacy, evaluated by the percentage of regression of BE after ablation at a particular dose with the Full Ablation System.

  • A Study to Characterize the Performance of Brain Laser (LITT) Ablation for Treating Epilepsy that is Resistant to Medical Therapy Jacksonville, FL

    The purpose of this study is to characterize theuse of the Monteris NeuroBlate System for theperformance of brain laser interstitial thermal therapy (LITT) ablation treatment of medial temporal lobe epilepsy that is resistant to medical tharapy.

  • NOLA (NeuWave Observational Liver Ablation) Registry Jacksonville, FL

    The purpose of this study is to create a registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

  • Ventricular Arrhythmia Increases Sympathetic Activity Determined By A Skin Nerve Recording Rochester, MN

    The purpose of this study is to utilizeneuECG, a new method to directly and non-invasively record skin sympathetic nerve activity (SKNA) and electrocardiogram (ECG), to non-invasively assess the effects radiofrequency catheter ablation (RFCA) on SKNA in patients at high risk for life-threatening ventricular arrhythmias (VA).

  • A Study to Compare Anticoagulation with Left Atrial Appendage Closure after AF Ablation Rochester, MN

    The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

  • Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia Rochester, MN

    The purpose of this study is to demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic and non-ischemic) while maintaining an acceptable safety profile.

  • Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of the study is to look at the safety and effectiveness of using BioTraceIO Lite software during an ultrasound for patients who are having a liver ablation procedure.

  • The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors Rochester, MN

    Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung tumors.

  • Immunomodulation and Patients` Outcomes Following Treatment of Hepatocellular Carcinoma by Radiofrequency Ablation, Microwave Ablation, Trans-Arterial Chemoembolization or Radio-embolization Rochester, MN

    The goal of the study is to identify immune responses (immune cell activation and suppression) following local ablation of liver tumors.

  • A Study of Silent Cerebral Lesions in Patients Undergoing Left Heart Ablation for Ventricular Arrhythmia and Atrial Fibrillation Rochester, MN

    The purpose of thisstudy isto learn about the effect of atrial fibrillation on memory and thinking. This study helps us to determine how often memory problems occur in patients with atrial fibrillation and identify factors that influence changes in memory and thinking.

  • Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System Rochester, MN

    To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

  • A Study to Evaluate Software On Cross-sectional Imaging Evaluation of Microwave-ablated Liver Tumors Rochester, MN

    The primary purpose of this study is to assess the accuracy of the Philips High Precision 3D Ablation Solution software on cross-sectional imaging evaluation of microwave-ablated liver tumors, and to determine whether software accuracy varies based on patient, tumor, and technical procedural factors.

  • Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain Rochester, MN

    This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group ...

  • Pilot Study to Evaluate MR-guided Laser Ablation of Focal Lesions in Patients with Medically Refractory Partial Epilepsy Jacksonville, FL; Rochester, MN

    To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

  • MARK 1A Series: Percutaneous Microwave Ablation for Patients With Lung Tumor(s) Rochester, MN

    The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk.

  • Registration of Coronary Arteries through Electroanatomical Mapping System with CT Angiography Rochester, MN

    This study aims to perform a prospective analysis of patients undergoing fibrillation ablations and compare the validity of the electroanatomical registration with superimposed angiography. In addition, this study aims to compare and understand the relationship between the cardiac vessels.

  • Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT) Rochester, MN

    This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

  • A Study to Assess the BioTraceIO System for Identifying Tissue Damage from Microwave Thermal Liver Ablation Scottsdale/Phoenix, AZ

    The purpose of this study is toevaluate the accuracy of the BioTrace IO during RFA/MWA Transcutaneous procedures.

  • A Study to Analyze Biopsy of Vascular Malformations Rochester, MN

    The purpose of this study is to validate a core biopsy technique for obtaining tissue from treatment naive vascular anomalies for clinical pathology and genomic analyses in patientsundergoing clinically indicated sclerotherapy, embolization and/or ablation.

  • Quantitative Assessment of Tumor Ablation Rochester, MN

    The purpose of this study is to retrospectively analyze potential correlation between ablation zone/margin and tumor recurrence by using the Software Product to quantitatively evaluate diagnostic/pre-operative CT images, intra-operative CT images during ablation procedures, and follow-up CT images; and to apply and evaluate the FDA cleared Software Product during CT-guided ablation procedures for intra-operative monitoring and confirmation.

  • Pivotal Study of the NanoKnife System for the Ablation of Prostate Tissue Rochester, MN

    The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.

  • A Study to Evaluate Treatment of Papillary Thyroid Carcinoma with Radiofrequency Ablation Rochester, MN

    The purpose of this study isto evaluate the efficiency of Radiofrequency ablation (RFA) therapy to treat papillary thyroid carcinoma.

  • Study of NanoKnife for Ablation of Prostate Cancer in Low and Intermediate Risk Patients Rochester, MN

    The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.

  • An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue Rochester, MN

    To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.

  • A Study to Assess the Effectiveness and Safety of Durvalumab Alone or Combined with Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to test the validityof durvalumab and VEGF inhibitortherapy toenhance anti-tumor immune responses to produce significant and consistent clinical benefit in patients with Hepatocellular Carcinoma (HCC) after curative hepatic resection or ablation.

  • A Study Comparing Sublobar Resection versus Stereotactic Ablative Radiotherapy for Lung Cancer Rochester, MN

    The purpose of this study is to determine if Stereotactic Ablative Radiotherapy improves survival over sublobar resaction in high risk operable stage I non-small cell lung cancer.

  • A Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation Scottsdale/Phoenix, AZ

    This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

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