Implantable Cardioverter Defibrillator (ICD)

Researchers are exploring how deep brain nuclei activity and the cerebral cortex function during recovery from general anesthesia in patients undergoing deep brain stimulation (DBS) surgery. This study aims to understand the changes and connections between deep brain nuclei firing and cortical activity during the return of consciousness. The research focuses on the brain's neural networks involved in recovery, which is not just a passive drug clearing process but an active brain function. During the study, patients having DBS surgery will have their local field potentials (LFP) from deep brain nuclei and scalp electroencephalograms (EEG) from the frontal cortex recorded simultaneously. No additional interventions are given beyond the planned DBS surgery. These recordings occur during the recovery period after general anesthesia to analyze how signals from deep brain areas relate to cortical EEG activity. Participants will be monitored for changes in brain signals over about 2 hours during recovery from anesthesia. Researchers will evaluate the number of patients showing changes in LFP and EEG patterns. The study includes assessments of brain activity to better understand consciousness recovery mechanisms. Patients are expected to cooperate during surgery and recording, with the total observation focused on the immediate post-anesthesia recovery phase.

Researchers are evaluating the Turkish version of the Assessment of Quality of Life and Related Events (AQUAREL) scale specifically for patients with pacemakers. Cardiac implantable electronic devices, such as pacemakers, are commonly used to reduce serious heart rhythm problems and sudden cardiac death, but they can lead to complications that affect patients' quality of life. This study aims to test the validity and reliability of this Turkish adaptation to ensure it accurately measures quality of life in this patient group. The study involves patients who have pacemakers without current complications and covers those in all New York Heart Association (NYHA) classes I through IV. Participants will be observed over a one-year period, during which the Turkish AQUAREL scale will be applied and evaluated. The study focuses on assessing patients' quality of life, daily living activities, and comorbidity levels to understand the scale's effectiveness in this context. Participants will be monitored with scheduled assessments over the course of one year to measure quality of life using the adapted scale. Researchers will evaluate various outcomes including quality of life, daily activity levels, and comorbidity status. This observational study does not involve interventions but collects data to validate the scale's use for Turkish-speaking pacemaker patients, contributing to improving patient care and monitoring in clinical settings.

This research aims to evaluate the use of implantable cardioverter defibrillators (ICD) for preventing sudden cardiac death in patients aged 70 years and older who have an ICD indication for primary prevention. It specifically compares whether heart failure optimal therapy alone (HFOT) is not worse than combining HFOT with ICD implantation regarding overall survival at 48 months after randomization. The study addresses the lack of clear evidence about the benefit of ICDs in the elderly and seeks to understand if avoiding ICD implantation can reduce device-related complications and healthcare costs. Participants are randomly assigned to one of two groups: one group receives heart failure optimal therapy without ICD implantation, and the other receives optimal medical therapy plus ICD implantation. ICD devices used are any CE-marked brand available and reimbursed in the French market, implanted at the discretion of the local investigator. The study follows patients for four years after randomization, monitoring survival and health outcomes. During the study, participants undergo regular assessments including heart failure evaluations and quality of life questionnaires at multiple intervals up to 48 months. Researchers measure overall survival as the primary outcome and track cardiovascular mortality, sudden cardiac death, hospitalizations, ICD-related complications, and quality of life scores as secondary outcomes. The trial includes follow-up visits to monitor health status, treatment adherence, and complications to provide comprehensive data on the long-term impact of these treatment strategies.

This trial investigates the comparative effectiveness of two beta-blocker drugs, carvedilol and metoprolol succinate, in adults with heart failure with reduced ejection fraction (HFrEF) who have an implantable cardioverter defibrillator (ICD). The study aims to provide clear data on which medication better reduces the risk of ICD therapy, cardiovascular hospitalizations, or cardiovascular death. It is a prospective, multicenter, randomized clinical trial enrolling 2,000 participants across 100 U.S. sites, including an 18-month feasibility phase. Participants currently taking metoprolol succinate will be randomized to either continue this treatment or switch to carvedilol at an equivalent dose. Both groups will have their doses adjusted to the maximum tolerated level as per the study protocol. The feasibility phase will evaluate recruitment, safety, adherence, and retention, while the full study will follow participants for up to three years, assessing clinical outcomes and quality of life. During the study, participants will undergo regular assessments including ICD device checks, laboratory tests, imaging, and surveys on quality of life and anxiety related to ICD shocks. Data collected will include cardiovascular events, healthcare use, medication adherence, and patient-reported outcomes measured at baseline and throughout the follow-up. The trial will also analyze results by patient subgroups such as age, sex, race, heart failure type, and ICD type to better understand treatment responses.

Researchers are evaluating the safety of early mobilization after implantation of intracardiac electronic devices, such as pacemakers or implantable cardioverter-defibrillators. The study compares mobilization at 4 hours after the procedure to the standard approach of mobilization the day after, aiming to provide guidance on the best timing to prevent complications. This trial is open, randomized, and controlled, focusing on whether early mobilization is not worse than the usual care. Participants are assigned to one of two groups: one with short-term bed-rest and mobilization starting 4 hours after the procedure, and the other following the standard care of bed-rest until the day after the procedure. Both groups undergo implantation of a new permanent pacemaker or defibrillator. The study monitors participants closely for safety and recovery during the first 48 hours after surgery. During the study, participants will be observed for complications such as pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion within 48 hours after the operation. Additional assessments include post-operative pain, sleep disturbance, urinary retention, delirium, orthostatic intolerance, quality of recovery, and pressure ulcers. The total study period includes close monitoring in the immediate postoperative phase to assess the safety and benefits of early versus delayed mobilization.

Researchers are investigating the economic and clinical benefits of remote monitoring (RM) for patients with implantable defibrillators (ICD) or cardiac resynchronizing therapy defibrillators (CRT-D). This study aims to identify which subgroups of defibrillator patients benefit most from RM by comparing outcomes across different indication groups. The study is being conducted as a prospective clinical trial in the Korean population to help guide recommendations for RM use. The study will enroll 556 patients who have received ICD or CRT-D implants. Participants will be randomly assigned to one of two groups: one group will have their RM function activated within 0 to 45 days after implantation and will typically visit the clinic once a year unless an adverse event occurs. The other group will follow conventional care without RM, attending clinic visits at intervals no longer than six months depending on center practice. Follow-up will continue for up to two years after device implantation. Participants will be monitored for major adverse events, including death from any cause, cardiovascular issues, and device- or procedure-related problems, over the two-year period. Economic benefits of RM will also be evaluated during this time. Study involvement includes scheduled clinic visits, remote monitoring alerts, and routine follow-up assessments to track health outcomes and healthcare costs. The total participation duration is two years with ongoing safety and clinical evaluations.

Researchers are evaluating a home-based exercise program called Exercise-ICD (E-ICD) for people who have an implantable cardioverter defibrillator (ICD). The study aims to test how effective this exercise intervention is and to understand how it can be implemented by cardiac rehabilitation staff. The study involves 210 participants across three local sites and uses a randomized two-group design comparing E-ICD to usual care, focusing on increasing physical activity and improving quality of life while reducing anxiety and depression related to ICD shocks. The E-ICD intervention consists of 12 weeks of home walking exercise designed to meet a goal of 30 minutes on most days at a moderate level. Participants receive exercise instructions through a DVD and manual, monitoring tools like a heart rate monitor and exercise logs, and telephone coaching from cardiac rehabilitation staff. After the 3-month intervention, participants are given a tailored exercise prescription to maintain or increase their activity over the next 3 months. The usual care group continues their standard follow-up and ICD monitoring without specific exercise guidance but is tracked for physical activity and healthcare use. Participants will be assessed at the start, after 3 months, and again at 6 and 12 months. Researchers will measure physical activity using daily step counts, health status, mobility, confidence in walking, anxiety related to ICD shocks, and depression. The study also monitors how well the exercise program is adopted and implemented by clinical staff, participant satisfaction, and adherence. The total study duration per participant is 12 months to evaluate both immediate and longer-term effects of the exercise program.

Ventricular tachycardia (VT) is a serious heart rhythm problem that can lead to sudden cardiac death and other severe complications. This study focuses on patients with cardiomyopathy who have experienced VT, aiming to find the best treatment approaches to improve long-term outcomes. Researchers will also examine how VT affects patients in real-world settings, including treatment safety, effectiveness, adherence to guidelines, and cost-effectiveness. The study follows patients with ischemic and non-ischemic cardiomyopathy from their first VT event for at least three years or until death. Researchers will collect data remotely from implantable cardiac defibrillators (ICDs) and review these events carefully without knowing the patient's treatment or center. The goal is to identify the most effective treatment sequences to maximize event-free survival. Participants will be monitored through ICD remote tracking and clinical evaluations over time. The main outcome is to determine the best treatment plan for each patient over five years. The study also looks at how treatments are used in practice and differences in outcomes between men and women. Participants will be followed closely for safety and treatment results throughout the study period.

Researchers are evaluating two different regional anesthesia methods during the implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients aged 18 to 90 who require this cardiac procedure. This study aims to determine if the combination of superficial parastenal intercostal plane (SPIP) block plus superficial serratus anterior plane (SSAP) block is the optimal anesthesia form compared to the pectoserratus plane (PSP) block plus SSAP. The study includes patients at high anesthesia risk and uses a double-blind randomized design to objectively assess anesthesia quality and patient comfort. Participants are randomly assigned to one of two groups: Group I receives PSP+SSAP anesthesia, and Group II receives SPIP+SSAP anesthesia. Both groups receive a mixture of 0.125% ropivacaine and 0.25% lidocaine in a total volume of 60 mL administered under ultrasound guidance. During the procedure, short-acting intravenous analgesics and sedatives are given to maintain patient comfort and safety. Additional local anesthesia or intravenous pain medications may be administered if needed, with specific criteria for disqualification if dosages exceed limits. Throughout the procedure, patients’ pain levels and sedation status are monitored every 15 minutes using numerical and visual pain scales (NRS and VAS), Richmond agitation/sedation scale (RASS), and Glasgow coma scale (GCS). Vital signs including oxygen saturation, blood pressure, and heart rate are checked every 5 minutes. Postoperative pain is assessed every 6 hours for 24 hours, and patients complete a quality of recovery questionnaire 24 hours after surgery. The primary outcomes include pain, sedation, and operator comfort scores collected throughout and after the procedure.

Researchers are evaluating the use of the extravascular implantable cardioverter-defibrillator (EV-ICD) for patients at risk of sudden cardiac death due to cardiac arrhythmia. This observational study aims to collect real-world data on the long-term safety and effectiveness of this newer device design, which offers advantages over traditional implantable cardioverter-defibrillators by placing the lead in the substernal space. The study is conducted nationwide in France to provide comprehensive evidence beyond previous smaller, specialized center trials. The EV-ICD device studied involves implanting a pulse generator along the left midaxillary line with a lead positioned substernally. This device is designed to deliver pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to conventional ICDs but with potentially improved outcomes. The study includes all patients receiving an EV-ICD implant in France and observes them over an average follow-up period of five years. Participants will be monitored throughout the study period for appropriate device therapies, early and late complications related to the EV-ICD, and overall mortality. Additional outcomes include interventions during follow-up and heart transplantation rates. Data collection will occur from implantation through hospital discharge and continue for about five years to assess long-term safety and effectiveness in a real-world setting.