Loading clinical trials...
Loading clinical trials...
Showing 1-16 of 16 trials
NCT07322900
Chronic postsurgical pain (CPSP) remains a significant clinical and public health challenge despite major advances in surgical and anesthetic techniques. Patients receiving cardiac implantable electronic devices (CIEDs)-including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy devices (CRTs)-constitute a unique population with high rates of multimorbidity, psychological vulnerability, and limited analgesic options due to cardiovascular comorbidities. Insufficient postoperative pain management in this group may lead to persistent pain at the generator site, neuropathic pain features, reduced quality of life, and increased healthcare utilization. The present study aims to evaluate the prevalence, risk factors, and clinical predictors of CPSP following CIED implantation using both subjective and objective pain assessments. Pain intensity will be measured using validated self-report scales (Visual Analog Scale and DN-4 questionnaire), and objective pain thresholds will be determined using a calibrated digital pressure algometer. Quality of life will be assessed with the validated Turkish version of the Short Form-12 (SF-12) instrument. This prospective observational study will include 180 adult patients who underwent first-time CIED implantation at Istanbul University-Cerrahpaşa, Cardiology Institute. Participants will be evaluated at 3, 6, and 12 months post-implantation. Collected data will include preoperative, intraoperative, and postoperative variables such as demographics, comorbidities, anesthesia type, surgical duration, and acute postoperative pain control. Using the obtained data, an artificial intelligence-based clinical decision support system will be developed to predict individual CPSP risk before implantation. The model will integrate subjective scales, objective algometric data, and clinical factors to generate personalized risk estimates. Ultimately, this system aims to improve early detection and prevention of CPSP, optimize postoperative pain management strategies, and enhance patient quality of life.
NCT05958290
The goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (CIED) infection in patients where device extraction is not feasible. The main question it aims to answer: • Is 6-weeks medical therapy effective in curing definite CIED infection with device retention? Participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. After discontinuation of antibiotics, patients are closely observed for bacterial relapse. For patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.
NCT04600921
The recent study is planned to investigate the impact of Ertugliflozin on total burden of ventricular arrhythmias. Further objectives will be number of therapeutic interventions of implanted devices, atrial fibrillation, heart failure biomarker and changes in physical function quality of life, stress and anxiety.
NCT06842940
The goal of this observational study is to identify the most reliable electrical parameter measured at the time of implantation that can predict optimal lead fixation and long-term lead performance in patients undergoing transvenous pacemaker or implantable cardioverter-defibrillator (ICD) implant. The main questions it aims to answer are: * Is there a correlation between the slew rate measured at the time of lead implantation and the sensing measured at the 12-month follow-up? * Is there a correlation between all electrical parameters recorded at implantation (including slew rate, current of injury, acute sensing, acute impedance, and acute pacing threshold) and the electrical parameters assessed at 12 months post-implantation (specifically chronic sensing, chronic impedance, and chronic pacing threshold)? Participants will undergo regular follow-up evaluations, with device interrogation visits scheduled at 1 and 12 months post-implantation as part of routine clinical care.
NCT06597578
The KOBES registry is an all-comers prospective clinical registry of the cooperative Köln Bonn lead extraction center. All patients undergoing complex lead extraction procedures (i.e. indwelling leads \> 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. Preoperative, intraoperative/procedural and postoperative parameters will be recorded. All patients will be asked to provide written informed consent. Data will be pseudonomyzed and entered into a data sheet. Data will be monitored by a board and evaluated independently.
NCT06503445
Cardiac rehabilitation has the beneficial effects of secondary prevention and social psychological and physical health status in patients with cardiovascular diseases. International and clinical guidelines currently recommend exercise training and rehabilitation for heart failure patients, which can effectively improve mortality and prognosis. However, few of these recommendations have specific recommendations for patients with cardiac implantable electronic devices. Currently the recommendations of cardiac rehabilitation include patients with coronary heart disease (acute coronary heart disease, any coronary revascularization, stable coronary disease or unstable angina), patients with heart failure, after cardiac surgery, and patients with high cardiovascular risk. Many of these patients may be implanted with cardiac implantable electronic devices. In 2011, 938 pacemakers, 140 cardiac resynchronization therapy and 149 implantable cardioverter defibrillators were implanted per million inhabitants in Europe. Therefore, among the groups with cardiac implantable electronic devices, cardiac rehabilitation plays a certain role. The purpose of this study is to evaluate whether video-based cardiac rehabilitation health education for patients with cardiac implantable electronic devices has significantly improved physical activity. This study is designed as a prospective, single center, double-blind, randomized controlled trial. Divided into an experimental group and a control group at a ratio of 1:1. The experimental group with cardiac implantable electronic devices will receive cardiac rehabilitation health education video intervention, and the control group will receive only health education. We aim to recruit 45 participants per group with a total of 90 participants.
NCT02513056
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and clinical need for MRI.
NCT01847625
The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.
NCT03579641
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.
NCT03842124
Death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. These complications are due to abnormal force vectors during the procedure. The investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital force gauge is associated with minimal lead displacement compared to conventional lead extraction. Lead displacement is an indirect risk factor for potentially fatal lead extraction complications
NCT03614377
This prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.
NCT03521050
All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.
NCT02323503
Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) \<35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question. 80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device. So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
NCT01097330
Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as ventricular tachycardia (VT). ICDs are very successful in bringing back a normal heart beat when VT occurs, but they do not prevent further dangerous heart rhythms from occurring. This study is designed to determine the best way to manage patients who have an ICD and who continue to have episodes of VT. There are two methods for treatment the VT: 1) Ablation, and 2) Medication. An ablation procedure involves placing a flexible catheter (insulated wire) in the groin area and threading it into the heart. After the doctor has located the affected area responsible for the VT, radiofrequency energy is delivered by the power generator through the catheter to the inside of the heart. The radiofrequency energy ablates (burns) a small area of the heart tissue thought to cause the VT. A medication called Amiodarone is an "anti-arrhythmic" prescribed to prevent abnormal heart rhythms from recurring. The purpose of this study is to compare these two different methods for treating VT. Treatment with ablation and amiodarone are both considered the standard of care for patients with VT but they have not been compared directly in a study like this before.
NCT03827915
Atrial fibrillation (AF) is a common cardiac arrhythmia that leads to increased risk of heart failure, hospitalization, thromboembolic events, and death. Restoration of normal heart rhythm is performed in many patients with AF to improve symptoms. In this study, the investigators will consider patients who fail 2 or more trials of DC cardioversion as having refractory AF. The aim of this study is to assess whether the use of double sequential defibrillation in patients with refractory AF has a higher success rate in reverting them to a normal heart rhythm than a third cardioversion. This is a phase III, randomized controlled, single-centered, superiority trial. All patients with AF admitted to the coronary care unit (CCU) for DC cardioversion, and refractory to at least two trials of DC cardioversion will be enrolled. Patients are randomized into two arms: the first will receive a third trial of DC cardioversion (standard of care) and the second will receive double sequential external defibrillation. The resolution of AF by reverting back to normal sinus rhythm is the primary outcome of the investigators. This will be determined using EKG (electrocardiogram) immediately after DC cardioversion or double sequential defibrillation.
NCT01006746
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring implementation.