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Tachycardia, Ventricular clinical trials

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NCT ID: NCT00858559 Terminated - Cardiac Pacing Clinical Trials

Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)

ANVITE
Start date: March 2009
Phase: N/A
Study type: Interventional

Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician. In the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme.

NCT ID: NCT00853645 Completed - Clinical trials for Ventricular Tachyarrhythmias

Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System

Chronic II
Start date: July 2008
Phase: N/A
Study type: Interventional

Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.

NCT ID: NCT00851279 Completed - Clinical trials for Ventricular Tachycardia

Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia

STOP-VT
Start date: June 2009
Phase: Phase 4
Study type: Interventional

This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.

NCT ID: NCT00846417 Terminated - Clinical trials for Ventricular Tachycardia

Implantable Cardioverter Defibrillator (ICD) Support Groups and Veterans

Start date: July 2008
Phase: N/A
Study type: Observational

In this study, we will compare the quality of life in veterans having ICD who attend the ICD support groups to those who do not. We ask them to answer a set of quality of life questionnaires at baseline and then at 3,6,9 and 12 month visits. These questionnaires would be analyzed to assess if attending support groups made a difference. These results will be compared to a similar study done at Emory University on non veterans.

NCT ID: NCT00833352 Completed - Clinical trials for Ventricular Tachycardia

Comparison of Right Ventricular Septal and Right Ventricular Apical Pacing in Patients Receiving a CRT-D Device

SEPTAL-CRT
Start date: November 2008
Phase: N/A
Study type: Interventional

This prospective, randomized, single blind, multi-centre study will examine the effect of the right ventricular (RV) lead location in patients implanted with a cardiac resynchronization defibrillator. 1. Purpose : To compare the effect of RV mid-septal (RVS) versus RV apical (RVA) lead location on left ventricular reverse remodeling in patients indicated for cardiac resynchronization therapy device (CRT-D) over a period of 6 months and to evaluate the clinical outcome of the RVS versus RVA pacing, over a period of 12 months. 2. Objectives: The primary objective is to demonstrate that there is no difference between the two groups (RVA vs. RVS) in the change of left ventricular end systolic volume (LVESV), between baseline and 6 months. The secondary objectives are to evaluate the percentage of "echo-responders" plus additional clinical and safety outcomes. This prospective, randomized, multi-centre, single-blind with 2 parallel arms, non-inferiority study will be conducted in approximately 25 study centres in Europe. The patients will be randomized in a 1:1 ratio. A maximum of 416 patients will be enrolled in this study. All eligible patients will be followed through baseline, randomisation, pre discharge, 1, 6 and 12 months post-implant. Enrolment is expected to be completed in 18 months. The total duration of the study is expected to be approximately 30 months.

NCT ID: NCT00832975 Completed - Atrial Fibrillation Clinical Trials

AVAI: Atrial Ventricular Arrythmia Incidence

AVAI
Start date: December 2008
Phase:
Study type: Observational

The purpose of this observational study is to collect data regarding the population of patients implanted with St. Jude Medical ICD.

NCT ID: NCT00800384 Completed - Clinical trials for Ventricular Tachycardia

Shockless Implant Evaluation

SIMPLE
Start date: January 2009
Phase: N/A
Study type: Interventional

This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

NCT ID: NCT00787800 Completed - Atrial Fibrillation Clinical Trials

The Use of Dual Chamber ICD With Special Programmed Features to Lower the Risk of Inappropriate Shock

RAPTURE
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The RAPTURE Study will determine whether dual chamber defibrillators with atrial prevention and termination therapies, minimized ventricular pacing, and remote monitoring will reduce the rate of inappropriate shocks and improve quality of life compared to optimally programmed back-up pacing only single chamber ICDs when used for primary prevention of sudden cardiac death

NCT ID: NCT00776087 Terminated - Clinical trials for Ventricular Fibrillation

European Health Economic Trial on Home Monitoring in ICD and CRT-D Patients (EuroEco)

EuroEco
Start date: October 17, 2008
Phase: N/A
Study type: Interventional

BIOTRONIK Home Monitoring (HM) service enables the doctors to safely follow up (FU) their ICD and CRT-D patients in a remote fashion, with fewer in-clinic consultations. This may result in a more efficient FU and cost-savings for the health care payer. The EuroEco study: 1. Outlines a new HM-based FU model for the ICD and CRT-D patients that combines in-clinic consultations and regular check ups of the patient/ICD/CRT-D data received through the HM service. 2. Compares the direct costs for physicians and clinics for the HM-based FU of ICD and CRT-D patients versus the traditional FU. 3. Compares the indicators of patients' safety between the two FU models.

NCT ID: NCT00749671 Terminated - Clinical trials for Tachycardia, Ventricular

Bispectral Index Monitoring During Testing in the Electrophysiology Lab

Start date: October 2007
Phase: N/A
Study type: Interventional

BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been the standard of practice for patients undergoing a wide range of electrophysiology procedures during the past decade. Currently a subjective sedation assessment tool is the standard of practice within the Electrophysiology Lab (EP Lab). Bispectral Index monitoring (BIS) is an objective measure of the depth of sedation presently employed at Baystate Medical Center in the Intensive Care Unit and within the department of anesthesia. AIM The aim of this research study is to assess the utility of BIS monitoring in measuring the depth of sedation in patients undergoing defibrillation threshold testing (DFT). Our primary endpoint is: A change in OAAS scores of one point at the 30 minute data collection time period. Our secondary endpoints are: Lack of explicit recall of DFT testing and measurement of perioperative level of comfort. STUDY DESIGN AND SCOPE The population to be studied is those patients receiving a primary ICD implant or an ICD battery change with defibrillation threshold testing (DFT). All patients who have consented for ICD placement and DFT testing with moderate sedation will be invited to participate in this research study. Patients who are not candidates for DFT testing, as is determined by the EP physician, will be excluded from the study. Demographic data including: age, gender, BMI, current medications and history of sleep apnea will be collected. Data detailing the amount of drug administered during the procedure and any use of reversal agents, will be retrieved from the medical record. The study will be conducted within the Electrophysiology lab at Baystate Medical Center. An enrollment of 60 subjects is expected to be completed within 6 months. 30 patients will originate from the outpatient population and 30 from the inpatient. Follow up assessments using the OAAS scale will be completed at 30 min, 1 hour and 4 hours post procedure. Also, perioperative comfort and recall of DFT testing will be assessed at the 4 hour mark.