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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT01829126 Recruiting - Clinical trials for Congestive Heart Failure

Development and Prevention of Severe Heart Disease in Systemic Sclerosis

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease. This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.

NCT ID: NCT01825525 Completed - Cardiac Arrhythmia Clinical Trials

Safety of the Colonoscope Magnetic Imaging Device (ScopeGuide®) in Patients With Implantable Cardiac Devices

Start date: August 2012
Phase: N/A
Study type: Interventional

The Olympus ScopeGuide® is a useful tool in speeding up colonoscopy and making it less painful for patients. It is currently contraindicated by the manufacturer for use with patients with implantable electronic devices (such as cardiac pacemakers). There is no evidence to back up this contraindication and with the number of pacemakers being inserted increasing by around 30 000 annually in the UK, more patients will be denied the use of this device should they require a colonoscopy. Participants with Pacemakers or Implantable Cardioverter Defibrillators will attend their check appointment. Following this they will be asked to lie with a colonoscope connected to the ScopeGuide® placed onto their abdomen (with clothes on) for 2 minutes. During this time they will be monitored for any irregular cardiac activity which may indicate electromagnetic interference. After this a second device check will occur and the participant will be sent home. The hypothesis is that the ScopeGuide will not interfere with the cardiac devices.

NCT ID: NCT01796353 Completed - Sexual Dysfunction Clinical Trials

Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients

CopenHeartSF
Start date: February 2013
Phase: N/A
Study type: Interventional

The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component. The primary hypothesis is that, a comprehensive sexual rehabilitation program improves sexual function.

NCT ID: NCT01785498 Completed - Cardiomyopathy Clinical Trials

Healthy Lifestyles for Children With Complex Heart Problems

ReACH
Start date: January 2012
Phase: N/A
Study type: Interventional

Healthy Lifestyles for Children with Complex Heart Problems is a planning and resource development project. The goal of the project is to develop an implementation plan that would enable children with complex heart problems to lead healthy, active lives within their own community. The primary goal of the project is to promote physical activity, because the physical and mental health benefits of activity are very important for these children. Children with complex heart problems have a higher risk for obesity, diabetes, acquired heart disease and mental health problems than their healthy peers. The physical health benefits of physical activity are well known, but physical activity is also key for children's mental health. Physical activity enables children to socialize with peers and create bonds and friendships. Physical activity participation also directly elevates mood through the release of brain chemicals. Children with complex heart problems are also known to experience fear and anxiety related to physical activity. This project will also develop strategies to promote healthy eating and the prevention of physical activity-related injuries to these children and their families. Children with complex heart problems are at higher risk of overweight and obesity and face unique injury risks related to pacemakers or their medications. Extensive consultations with families and caregivers have identified needed supports for physical activity lifestyles, mental health, healthy eating and injury prevention for these children. The goal of the interviews was to understand the positive and negative influences on physical activity and healthy lifestyles for these children. Analyses of the interview content was used to develop a detailed, step-by-step implementation plan to provide the supports necessary for children with complex heart problems to lead active, healthy lives in their own community, with their family and friends. The implementation plan specifies changes to family education and counselling resources, clinical care routines, and communication among professionals and families. The clinical trial will evaluate the impact of implementing the family supports and changes to practice previously developed. Surveys will be completed by families attending the cardiac clinic before and after the changes to practice and additional resources are made available. Interviews will be utilized to gather additional feedback from professionals and families that receive counselling utilizing the supplementary materials.

NCT ID: NCT01780337 Recruiting - Cardiac Arrhythmia Clinical Trials

Oxytocin Effects on Cardiac Electrophysiology

Start date: January 2013
Phase: Phase 0
Study type: Interventional

In this pilot study the investigators will perform a double-blind randomized trial of intranasal oxytocin on measures of cardiac refractoriness, among individuals who are undergoing clinically indicated catheter ablation procedures for paroxysmal atrial fibrillation. The investigators seek to enroll 20 patients for this study, for the purpose of estimating effect sizes for a larger future study.

NCT ID: NCT01723761 Completed - Cardiac Arrhythmias Clinical Trials

Correlations Between Arrhythmias and Air Pollution in Patients With Pacemaker and ICD

ARIA
Start date: April 2011
Phase: N/A
Study type: Observational

It is a clinical, observational study to evaluate the correlations among arrhythmias, climatic variables and air pollution in patients with pacemaker and implantable defibrillator (ICD), followed by remote monitoring. Purpose of the Study: The purpose of this study is to test the hypothesis that changes in climatic variables, such as temperature, pressure and humidity, and changes of particulate matter <10µ (PM10), particulate matter <2.5µ (PM2.5), ozone (O3), carbon monoxide (CO), sulfur dioxide (SO2), nitrogen dioxide (NO2), are associated with an increase of supraventricular and ventricular arrhythmias. Objectives: The aim of this study is to determine whether changes in variables conditions affect the electrical stability of the myocardium in patients with pacemakers and ICDs. Population: male and female subjects, aged ≥ 18 years, implanted by a dual-chamber pacemaker, ICD or biventricular ICD (ICD-CRT). A total of 500 subjects from 15 cardiology centers of the Veneto region will be included.

NCT ID: NCT01723566 Completed - Clinical trials for Heart Rhythm Disorders

PANORAMA 2 Observational Study

Start date: July 25, 2012
Phase: N/A
Study type: Observational

Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability. The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.

NCT ID: NCT01719978 Completed - Cardiac Arrhythmias Clinical Trials

Hemodynamic and Electrocardiographic Effects of Hyaluronidase Associated With Local Anaesthetics

Start date: October 2007
Phase: Phase 4
Study type: Interventional

Among the adjuvants to local anaesthetics (LA), the enzyme hyaluronidase is most often used as a diffuser agent of the LA in ophthalmic anaesthesia. It serves to improve clinical efficacy and prolong anaesthesia as an alternative to long-lasting and potentially more dangerous LA, especially in patients with increased cardiovascular risk. There is scarce clinical data about the safety of the use of hyaluronidase in dental procedures. This study aimed to compare hemodynamic and electrocardiographic variables during a dental surgical procedure using a local anaesthetic associated with hyaluronidase or placebo in healthy subjects.

NCT ID: NCT01716351 Completed - Cardiac Arrhythmias Clinical Trials

The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients

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

Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of life in ICD patients. The specialized, real-time data, collected by the device provides a unique look at the electrophysiological parameters of each patient's heart.

NCT ID: NCT01715116 Unknown status - Cardiac Arrhythmias Clinical Trials

ENHANCED Device Programming to Reduce Therapies and Improve Quality of Life in Implantable Cardioverter Defibrillator (ICD) Patients

ENHANCED-ICD
Start date: April 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Enhanced device programming to reduce therapies (i.e. anti tachycardia pacing (ATP) episodes and shocks (both appropriate and inappropriate)) is safe for patients implanted with an Implantable Cardioverter-Defibrillator (ICD). The secondary objective is to examine the impact of Enhanced programming on (i) ATPs and shocks (both appropriate and inappropriate) and (ii) quality of life and distress.