Tachycardia

The trial investigates the treatment of postinduction hypotension, a common complication during emergency abdominal surgery caused by factors like sepsis and low blood volume. This condition can lead to serious organ damage, so preventing and managing it quickly is important. The study compares two doses of norepinephrine bolus5 mcg and 10 mcgto find the best approach for treating low blood pressure in this setting. Participants will be randomly assigned to receive either a 5 mcg or 10 mcg norepinephrine bolus if their mean arterial pressure drops below 65 mmHg during surgery. The drug is prepared by diluting norepinephrine to a concentration of 10 mcgmL, then further diluted for dosing. If blood pressure does not improve within 2 minutes, the bolus may be repeated up to three times, followed by an infusion if needed. Fluid status will be assessed using leg raising maneuvers and fluid boluses before surgery, and heart rate and blood pressure will be monitored every 2 minutes for 30 minutes after skin incision. During the study, participants will undergo close blood pressure and heart rate monitoring at specified intervals. Researchers will measure the success of managing hypotension from anesthesia induction until 30 minutes after surgery begins. They will also assess the time and extent of low blood pressure, episodes of slow heart rate, and high blood pressure. The entire participation period covers the time from anesthesia induction to 30 minutes post-incision, focusing on immediate treatment response and safety under surgical conditions.

Researchers are evaluating the potential benefits of implanting an implantable cardioverter defibrillator ICD in patients with coronary artery disease who have survived cardiac arrest caused by ventricular fibrillation or sustained ventricular tachycardia. These patients have undergone complete revascularization and have a left ventricular ejection fraction LVEF above 35%. The study aims to assess whether ICD implantation can improve survival outcomes compared to standard medical therapy. Participants are randomly assigned to one of two groups one group receives an ICD implanted either during admission or within 4 weeks after discharge from the initial cardiac event, while the other group receives guideline-directed medical therapy without ICD implantation. The study compares these approaches to understand the effect of ICDs on survival in this patient population. During the study, participants will be monitored for outcomes including all-cause mortality over a five-year period, as well as mortality related to cardiovascular causes at one year. Researchers will collect data on sudden cardiovascular death and cardiovascular death within the first year. The trial includes follow-up assessments to track these outcomes and the overall health of participants throughout the study duration.

Researchers are evaluating CRD-4730, an oral drug, in a Phase 2 clinical trial involving adults with Catecholaminergic Polymorphic Ventricular Tachycardia CPVT. This study aims to assess the safety, tolerability, pharmacokinetics PK, and pharmacodynamics PD of CRD-4730. Participants will be part of a randomized, double-blind, placebo-controlled crossover study to better understand how CRD-4730 affects CPVT symptoms and treatment responses. Participants will be randomly assigned to one of three sequences in a 3-period crossover design. Each participant will receive two different doses of CRD-4730 and one matching placebo dose in a random order. The study includes multiple dosing periods where participants take tablets of CRD-4730 or placebo, allowing researchers to compare the effects and tolerability of different doses against placebo. During the trial, participants will undergo various assessments to monitor safety, drug levels, and effects on their condition from baseline to Day 101. The study involves close monitoring of heart function and other health measures, with outcome evaluations occurring at multiple timepoints. This will help researchers understand how the drug behaves in the body and its impact on CPVT symptoms, with the trial lasting several months to complete all study periods and follow-ups.

Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart in patients with various arrhythmias. This device is studied in individuals undergoing clinically indicated catheter mapping and ablation procedures for managing arrhythmias such as ventricular tachycardia, atrial fibrillation, and premature ventricular contractions. Participants will undergo catheter mapping and ablation using the investigational multi-electrode mapping catheter during their scheduled procedures. The catheter is used to perform high-density mapping of the hearts electrical activity to guide treatment. The study focuses on the devices safety, including serious adverse events within 7 days post-procedure, and its ability to complete all required pre-ablation mapping tasks. Evaluation includes physician assessments of the catheters deployment, maneuverability, and signal quality. During the study, participants will be monitored for safety outcomes up to 7 days after the procedure. Researchers will collect data on adverse events, mapping completion, and device performance. Participants must comply with all pre-procedure, post-procedure, and follow-up testing and requirements. The studys total duration includes the procedure day and a 7-day follow-up period to assess device-related safety and effectiveness parameters.

Researchers are evaluating the safety and effectiveness of the Dual Energy THERMOCOOL SMARTTOUCH SF catheter combined with the TRUPULSE generator for treating ventricular arrhythmias. This study focuses on whether the abnormal heart rhythms, including premature ventricular complexes and sustained monomorphic ventricular tachycardias, can be successfully treated using a specific procedural workflow during cardiac ablation. The trial also monitors participant safety by checking for any complications after the procedure. Participants undergo catheter ablation using the Dual Energy THERMOCOOL SMARTTOUCH SF catheter with the TRUPULSE generator, which delivers radiofrequency and pulsed field energy mainly as RFPF stacking applications according to the studys procedural workflow. The study groups include those being treated for premature ventricular complexes and different types of sustained ventricular tachycardia. The study tracks the procedures effectiveness and safety over several months following the ablation. During the study, participants are monitored with assessments including electrocardiographic data review, tracking of adverse events up to six months post-procedure, and intraoperative measurements such as procedure time, mapping details, and ablation parameters. Researchers measure the success of the procedural workflow at 3 months for premature ventricular complexes and at 6 months for ventricular tachycardia cases. Safety is closely observed up to 7 days and 6 months after the ablation to detect any adverse effects or complications.

Researchers are evaluating pyridostigmine compared to a placebo for treating postural tachycardia syndrome POTS, a condition characterized by rapid heart rate and symptoms like weakness and lightheadedness when standing. This phase 2 study aims to see if pyridostigmine can improve heart rate and stabilize blood pressure in people with POTS. The study is double-blind and placebo-controlled, meaning neither participants nor doctors know who receives the active drug or placebo during the trial. Participants will be randomly assigned to one of two groups one taking 180 mg of time-release pyridostigmine daily, and the other taking a placebo capsule daily, both for 3 days. The study includes two visits to the outpatient General Clinical Research Center. The first visit lasts about 3 hours, and the second visit occurs 2 days later, lasting about 2 hours. During these visits, various tests and procedures assess autonomic and cardiovascular function. During each visit, participants will undergo a medical and neurological exam, height and weight measurement, and complete questionnaires about autonomic symptoms. Tests include an autonomic reflex screen with sweat gland response, cardiovascular recordings, the Valsalva maneuver, and a head-up tilt test. Blood samples will be taken to measure hormone levels while lying down and after standing. Researchers will measure changes in orthostatic symptoms using the Composite Autonomic Symptom Scale and monitor heart rate and plasma norepinephrine changes. Safety and response will be closely observed throughout the short study period.

Researchers are investigating the safety and tolerability of a single intravenous dose of SGT-501 gene therapy in people with catecholaminergic polymorphic ventricular tachycardia CPVT, a rare heart rhythm disorder. This Phase 1b study focuses on adults initially, with later inclusion of children aged 7 to under 18 years, following safety reviews. The study aims to collect early safety data and understand the effects of this gene therapy over time. Participants will receive one intravenous infusion of SGT-501 at different dose levels depending on their age cohort. Adults aged 18 and older are divided into two cohorts receiving different doses, while children aged 7 to under 18 years will receive a dose at or below those given to adults. The study includes an active treatment period of one year followed by a long-term follow-up of four years to monitor participants health and response after treatment. During the study, participants will be monitored closely for treatment-emergent adverse events up to one year after the infusion. Researchers will assess ventricular arrhythmia scores through exercise stress tests at baseline and six months. Participants will undergo safety evaluations, laboratory tests, and disease monitoring over five years in total, including the long-term follow-up period. This extended observation ensures careful evaluation of the gene therapys effects and safety.

Researchers are evaluating the usability of the WearLinq eWave patch, a wearable multi-channel ECG monitoring device, in a general adult population. The study includes healthy adults as well as those with heart disease, arrhythmia, or other cardiac conditions. The goal is to understand how well participants can use this device and to monitor its wear duration and any adverse events during usage. Participants will apply the WearLinq patch continuously for 7 consecutive days in the primary study group. A smaller group of participants will be asked to use the patch for an extended period of 30 consecutive days. The patch continuously tracks cardiac rhythm by monitoring electrical activity from the chest area. During the study, participants will be monitored for how long they wear the device and for any adverse effects related to its use. Researchers will collect data on device adherence and safety outcomes over the wear periods. The total study duration for participants varies depending on whether they are in the 7-day or 30-day use groups, with all assessments focused on supportive care and device usability.

Researchers are studying atrial tachycardia AT that occurs after ablation of atrial fibrillation AF or cardiac surgery. This condition is difficult to treat due to the complex nature of the heart tissue and the mechanisms causing AT. The study aims to compare two methods of catheter ablation for ATstandard versus minimalized approachesto see which leads to better arrhythmia-free survival. The trial is prospective, randomized, and conducted at multiple centers to improve understanding using new ultra-high-density mapping techniques. Participants will receive catheter-based ablation using radiofrequency to treat their AT. They will be randomly assigned to either a standard ablation approach or a minimalized ablation approach targeting the clinical AT. The study will evaluate various procedural details such as procedure duration, fluoroscopy time, radiofrequency application time, ablated heart area, and the number of blocked lines. Both groups will be monitored during the procedure with advanced mapping techniques to assess the underlying heart substrate and AT mechanisms. During the study, participants will undergo assessments including ECG documentation of AT, intraprocedural mapping, and evaluations of arrhythmia recurrence over one year. Researchers will measure the recurrence of sustained arrhythmia lasting more than 30 seconds as the primary outcome after one year. Other measures include inducibility of AT after ablation, predictability of secondary AT from mapping, and procedure-related parameters. Participants will be followed for safety and treatment effectiveness throughout the study period, which started in December 2020 and is expected to continue until June 2027.

Researchers are investigating the role of focal electrical activations in maintaining persistent atrial fibrillation AF. The study evaluates a new mapping technique called RETRO-Mapping, designed to detect these focal activations during AF. This approach aims to better understand the mechanisms behind persistent AF and whether targeting these focal drivers can improve treatment outcomes compared to standard care. All participants will undergo a standard pulmonary vein isolation PVI procedure using advanced 3D electroanatomic mapping systems. After PVI, patients are randomly assigned to either a control group, which receives RETRO-Mapping without additional ablation, or an intervention group, where RETRO-Mapping is used to identify and ablate focal activation sites. The intervention includes mapping 30-second segments of the atria, ablating identified focal activations, and assessing changes in AF cycle length to evaluate treatment effects. Participants will be monitored through detailed intra-procedural measurements, including AF cycle length in the coronary sinus and left atrial appendage. The main outcome is the change in AF cycle length during the procedure, and a secondary outcome is freedom from AF one year after treatment. The study involves follow-up assessments and safety monitoring, with a total participation duration extending to at least one year to track long-term effects and recurrence.