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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT05258422 Enrolling by invitation - Clinical trials for Ventricular Tachycardia

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)

StAR-VT
Start date: July 1, 2023
Phase: Phase 2
Study type: Interventional

In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by noninvasive cardiac mapping. More recently, Robinson et al. reported on the results of their Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia (ENCORE-VT) trial, also using a similar SBRT technique in a series of 17 patients with refractory VT. Both studies report a marked reduction in VT burden, a decrease in antiarrhythmic drug use, and an improvement in quality of life. Since then, numerous other centres have detailed their initial experience with this technique. These initial results suggest that this new treatment paradigm has the potential to improve morbidity and mortality for patients suffering from treatment-refractory VT by means of a minimally invasive technique, but requires further validation for widespread use. The appropriate dose for therapeutic effect of this new treatment is not well established as only a single dose prescription of 25 Gy in 1 fraction has been described with benefit. In this phase 2 trial, the investigators plan on expanding the experience with this technique but also by contributing to understanding the relationship between dose-effect relationship through a dose de-escalation stratification, to 20 Gy in 1 fraction, with the goal of minimizing possible adverse events and radiation dose to surrounding healthy tissue while maintaining a clinical benefit.

NCT ID: NCT05252702 Active, not recruiting - Bradycardia Clinical Trials

Aveir DR i2i Study

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveirâ„¢ Dual-Chamber (DR) Leadless Pacemaker system.

NCT ID: NCT05247320 Completed - Atrial Arrhythmia Clinical Trials

Prospective Evaluation Analysis and Kinetics Registry

PEAKS
Start date: February 4, 2022
Phase:
Study type: Observational

In a cohort of patients electively treated for atrial arrhythmia with IV sotalol (initiation or dose escalation), this study will describe patient characteristics, short-term safety and efficacy, electrocardiographic monitoring, and PK and PD parameters (in a subset) associated with IV dosing approach.

NCT ID: NCT05239364 Recruiting - Heart Diseases Clinical Trials

Ablation of Consecutive Atrial Tachycardia

CONCLUDE
Start date: December 22, 2020
Phase: N/A
Study type: Interventional

Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.

NCT ID: NCT05222711 Not yet recruiting - Asthma Clinical Trials

The Use of a Monitoring Device by General Practitioners During Out-of-hours Care

Start date: May 2022
Phase: N/A
Study type: Interventional

All calls that end up on the out-of-hours general practitioners' service (OHGPS), which contain a demand for an urgent home visit, are passed on to the on-call general practitioner (GP). These calls are randomized into two arms: after the patient's informed consent, they are assigned either to one arm where the monitoring device, PICO, is applied together with the GP's general care or to the other arm where only the usual care is provided. All data such as suspected diagnosis, treatment or referral, influence of the parameters, ECG and/or alarms on the management and the user-friendliness are recorded. After 30 days, the diagnosis and evolution is requested from the patient's own GP or, if referred to a hospital, in the hospital in order to be able to compare the effect of the approach by the GP between both arms. The aim is to investigate if 1/ the use of the PICO monitoring device could improve GPs' decisions to refer to hospital or not in urgent cases; 2/ there is a difference between the diagnosis with and without the use of the monitoring device using the final diagnosis by the electronic health record of the own GP of the patient; 3/ the call to send a GP for an emergency contained sufficient information for the OHGPS phone operator to take an appropriate decision; 4/ the build-in alarms help the GP during his intervention; 5/ the PICO is easy to use during an emergency; 6/ the use of the device makes them feel more confident in transmitting the information to the Medical Emergency Team.

NCT ID: NCT05217485 Not yet recruiting - Atrial Fibrillation Clinical Trials

Continuous Ambulatory Cardiac Monitoring for Recurrent Atrial Fibrillation After Sepsis

CAMS-AF
Start date: March 2022
Phase: N/A
Study type: Interventional

To detect atrial fibrillation after infection.

NCT ID: NCT05214170 Recruiting - Atrial Fibrillation Clinical Trials

Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

Start date: June 7, 2021
Phase: N/A
Study type: Interventional

The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.

NCT ID: NCT05213104 Active, not recruiting - Clinical trials for Patent Foramen Ovale

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

AFLOAT
Start date: March 23, 2022
Phase: Phase 3
Study type: Interventional

About 30% of ischemic strokes are cryptogenic. Patent Foramen Ovale (PFO) is present in about 25% of the general population. In cryptogenic strokes, PFO has been shown to be overrepresented and recent intervention studies have confirmed that PFO has a causal link with stroke. In patients with recent cryptogenic stroke, these randomized studies have shown at least 50%-reduction of recurrent neurological events after PFO percutaneous closure compared with medical therapy alone. At the The risk of AF reported in these studies in certainly largely underestimated as only symptomatic and recorded episodes of AF have been declared. Patients often report palpitations without a dia gnosis of AF made on the ECG or a Holter. Long term ECG monitoring provides more accurate data on AF incidence. Administration of flecainide has been shown to be effective in preventing Atrial arrhythmia and may be useful in preventing these Atrial arrhythmia(AA) episodes after PFO closure. To the knowledge of the investigators, there is no study assessing the efficacy of any antiarrhythmic drug in the prevention of AFafter PFO closure. AFLOAT will be the first randomized study to possibly validate flecainide to prevent Atrial arrhythmia in these patients.

NCT ID: NCT05211492 Recruiting - Chronic Pain Clinical Trials

Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

After one-stage hybrid arrhythmia ablation surgery there are possible side effects like acute and chronic pain. There is a lot of research surrounding these pains but not specifically after one-stage hybrid arrhythmia ablation surgery. The investigators want to research factors that may be associated with the absence of chronic pain after hybrid ablation include ketamine, peroperative opioids, loco-regional blocks, neuraxial blocks, wound infiltration, postoperative patient-controlled analgesia. The presence of corticosteroids or NSAIDS, will also be evaluated. Furthermore, non-adaptable factors such as genetics complicate the onset of chronic post-operative pain. Taking existing knowledge in this field into account, incidence risk as well as acute pain duration and intensity and their effects on chronic pain will become the primary focus of this study. The investigators will contact all patients who had a one-stage hybrid arrhythmia ablation surgery at UZ Brussels. Participants will be sent a questionnaire with a consent form in and a survey asking about their pain 3 months postop and their current pain management therapy.

NCT ID: NCT05206825 Recruiting - Cardiac Arrhythmia Clinical Trials

Evaluation of Electrocardiography Performed With Mobile ECG Devices in Cardiac Patients and Healthy Volunteers

Start date: January 2, 2022
Phase:
Study type: Observational

Electrocardiography is one of most basic laboratory tests in cardiology. Novel mobile ECG are becoming popular. The investigators aim to compare typical electrocardiographic measurements obtained with mobile ECG devices (Alivecor Kardia and Alivecor Cardia 6L) and 12-leads standard ECG (gold standard). The recordings will be compared by cardiologist paying special attention to heart rhythm disturbances, components of ECG curve and quality of recording.