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Defibrillators, Implantable clinical trials

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NCT ID: NCT05959993 Completed - Clinical trials for Defibrillators, Implantable

Human Care Model-Based Nursing Interventions on Psychosocial Adjustment

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The aim of the randomized controlled interventional study was to to evaluate the effect of human care model-based nursing interventions on psychosocial adaptation in patients with cardioverter defibrillator. A study was carried out on a sample of 64 patients who had been implanted with a defibrillator. The intervention group participants underwent six interviews at two-week intervals, during which a hybrid and structured nursing intervention was administered.

NCT ID: NCT05366660 Completed - Telemedicine Clinical Trials

Remote Programming of Cardiac Implantable Electronic Device

REACT
Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. We aim to investigate the efficacy and safety of remote programming.

NCT ID: NCT04075253 Completed - Clinical trials for Tachycardia, Ventricular

Acute Effect of One Single Bout of High Intensity Exercise on the Tendency for Ventricular Arrhythmia

Start date: September 2, 2019
Phase: N/A
Study type: Interventional

This study will evaluate the acute effect of one single bout of high intensity exercise on the tendency for ventricular arrhythmia.

NCT ID: NCT04070300 Completed - Clinical trials for Tachycardia, Ventricular

Physical Activity and Ventricular Arrhythmias

Start date: September 2, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (ICD) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

NCT ID: NCT03579641 Completed - Heart Failure Clinical Trials

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

PREEMPT-HF
Start date: June 1, 2018
Phase:
Study type: Observational

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

NCT ID: NCT03271619 Completed - Cardiac Arrest Clinical Trials

Electrical Safety of Implantable Cardioverter Defibrillators

Start date: February 2014
Phase: N/A
Study type: Observational

Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock to the heart when indicated, in order to return the heart back to a normal rhythm. Many thousands of these devices have been implanted and are electrically active in patients who collapse and need resuscitation. When a patient with an ICD collapses, the device may discharge without warning while a rescuer is performing external chest compressions (cardiac massage). Conventional ICDs placed below the left collar bone typically deliver 35-50 J energy when they discharge, but newer ICDs placed under the skin (S-ICD) alongside the breastbone deliver a larger energy when discharging; typically 50-80J energy. Rescuers performing external chest compressions on a patient during conventional ICD discharge have reported the sensation of a painful electrical shock and permanent nerve damage. In these situations, rescuers appear to have been exposed to electrical current from the ICD considerably in excess of that which is considered a safe threshold. Studies of surface current resulting from discharge of conventional ICDs have been reported in excess of 100 mA which is far in excess of the safe 1 mA limit, and puts the rescuer at considerable risk of tissue damage and possible dangerous heart rhythms. The newer S-ICDs deliver approximately 50% more energy and have the potential to result in exposure of a rescuer to even higher currents. With increasing numbers of the S-ICDs being implanted, and the inevitability that rescuers will soon find themselves exposed to leakage current from these devices, there is a need to examine the leakage currents arising from these devices and assess any subsequent risk to a rescuer performing external chest compressions.

NCT ID: NCT01043562 Completed - Pediatrics Clinical Trials

Precise Measurement of Pediatric Defibrillation Thresholds

Start date: June 4, 2009
Phase: N/A
Study type: Observational

Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold testing, or DFT). This study proposes to perform that measurement in pediatric patients already undergoing clinically necessary ICD procedures, with the measurement performed using a binary search method that has been previously validated in adult cohorts. We hypothesize that pediatric DFTs, when precisely measured, may be lower than previously assumed from extrapolation of adult data.

NCT ID: NCT00845390 Completed - Clinical trials for Defibrillators, Implantable

Patient Expectations After Implantable-cardioverter Defibrillator (ICD) Implantation

Start date: December 2008
Phase:
Study type: Observational

This study will be a qualitative survey to understand the expectations of defibrillator patients with regards to their device. It is unknown what ICD (implantable-cardioverter defibrillator) patients understand about their device and its purpose, thus we will be talking to them about their device. Also, we will be interested in studying their beliefs on how the ICD impacts their life expectancy and quality of life.

NCT ID: NCT00598026 Completed - Telemedicine Clinical Trials

Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

EVATEL
Start date: January 14, 2008
Phase: N/A
Study type: Interventional

The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre. The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.

NCT ID: NCT00522340 Completed - Clinical trials for Heart Failure, Congestive

Exercise After an ICD

Start date: November 2007
Phase: Phase 2
Study type: Interventional

An implantable cardioverter-defibrillator (ICD) is a small device that is surgically implanted in the chest or abdomen and uses electrical pulses or shocks to help control life-threatening, irregular heartbeats. Increasing aerobic exercise may provide health benefits to people with ICDs. This study will examine the effects of an exercise program on heart and lung function in people who have an ICD.