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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT06260670 Completed - Clinical trials for Persistent Atrial Fibrillation

FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation

FLOW EVAL-AF
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions.

NCT ID: NCT05983484 Completed - Cardiac Arrhythmia Clinical Trials

Holter Versus Skiin Garments

Start date: October 16, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions: - Can the textile sensors provide continuous monitoring and detect arrhythmias? - Do patients prefer to wear textile sensors instead of the Holter? Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.

NCT ID: NCT05966922 Completed - Heart Arrhythmia Clinical Trials

Transcutaneous Electrical Stimulation & Sinoatrial Node Function

TENS&HR
Start date: July 13, 2023
Phase: N/A
Study type: Interventional

Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat a diverse range of medical conditions for over a century. Although the benefits of TES are well known, its potential side effects on the heart have not been convincingly clarified. This study will test whether TES has any effect on the sinoatrial node (SAN).

NCT ID: NCT05907863 Completed - Clinical trials for Heart Rhythm Disorder

Intracardiac Echocardiography Guided vs. Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia

Start date: April 1, 2022
Phase: Phase 4
Study type: Interventional

Study protocol To prepare for the electrophysiologic study, antiarrhythmic drugs were discontinued at least five half-lives before the procedure and were under conscious sedation using midazolam ± fentanyl while fasting. ICE-guided ablation group In patients randomized to ICE-guided ablation group, catheter placement was initially performed using fluoroscopy guidance, after local anesthesia. A decapolar steerable catheter was placed in the coronary sinus (CS), a quadripolar electrode catheter was positioned in the right ventricular apex and an ablation catheter was inserted to record the His bundle electrogram. Twelve-lead electrocardiogram and intracardiac electrograms were recorded and saved on a digital recording system using a band pass filter of 30 to 500 Hz. Electrical stimulation techniques were used to test atrioventricular nodal conduction and induce AVNRT, with the S2 coupling interval being gradually shortened after each drive-train until tachycardia was induced, AV conduction block occurred, or the atrial refractory period was reached. If tachycardia was not inducible, isoprenaline infusion was given to increase the heart rate by at least 20%, and the same stimulation protocol was repeated during both the infusion and washout phases. The diagnosis of AVNRT was made using established electrophysiologic criteria and pacing maneuvers. This involved assessing the A-(H)-V response after ventricular overdrive pacing, with an SA-VA interval greater than 85 ms, and a corrected postpacing interval minus tachycardia cycle length greater than 110 ms. After confirmation of the diagnosis of AVNRT through the diagnostic EP study, the quadripolar electrode catheter was removed and replaced with an 8F ICE catheter for mapping and SP ablation. The echo-transducer was positioned in the low right atrium at the 6 o'clock position and rotated clockwise towards the septum to allow for visualization of the anatomic landmarks. The proximity of the ablation catheter to the compact AV node was determined by the distance from the aortic valve, which marks the recording site of a proximal His potential. In cases of ineffective ablation, the catheter was moved closer to the aortic valve, but always maintaining a distance of at least 0.5 cm, and RF application was attempted again. RF energy was delivered starting just below the CS with a power output of 30 W and a preset temperature of 55°C. Effective applications were continued for 30 to 60 s and considered successful when junctional rhythm appeared. RF application was immediately halted if there was catheter displacement, sudden impedance rise, prolongation of PR interval, anterograde AV or retrograde VA block. Electroanatomical mapping system -guided ablation group An ablation catheter was inserted into the heart to create an anatomical map by CARTO of the right atrium after local anesthesia, and the location of the His bundle was tagged. Decapolar and quadripolar diagnostic catheters were positioned thereafter into appropriate position as described above. After confirming the diagnosis of AVNRT, mapping of the slow pathway was started by NAVISTAR catheter guided by EAMS and aiming at an atrial-to-ventricular electrogram amplitude ratio of 1:3-1:5. If the ablation endpoint was not reached after 8 radiofrequency (RF) applications, patients in the EMAS-guided ablation group were allowed to crossover to an ICE-guided procedure. The ablation procedure was deemed successful if, following a 20-minute waiting period, the arrhythmia failed to be induced and there were no instances of more than one echo beat observed, both in the presence and absence of isoprenaline. The procedure time was measured from the initial femoral puncture until the withdrawal of the catheters. The mapping plus ablation time was calculated from the start of the SP mapping until the end of the last attempted ablation. Fluoroscopy time, radiation dose, and dose-area product (DAP) were automatically recorded by the fluoroscopy system. The ablation data, including the total number of RF applications, sum of delivered RF energy in Watts, and the total ablation time in seconds, were calculated and stored by the EP recording system (CardioLab, GE Healthcare).

NCT ID: NCT05723744 Completed - Heart Arrythmias Clinical Trials

Anonymized Data Collection From the CS6BP for Heart Arrythmias Measurements

Start date: November 27, 2020
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to collect data simultaneously with the CS6BP watch sensors during EPS in order to characterize different evoked arrhythmias and record Blood Pressure during the procedures that blood pressure is collected by an automated cuff.

NCT ID: NCT05712122 Completed - Cardiac Arrhythmia Clinical Trials

Stellatar Ganglione Blockage for Ventricular Arrhytmias

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Ventricular tachycardia (VT) and ventricular fibrillation (VF) are life-threatening conditions that increase in frequency over the years. An electrical storm (ES) is defined as the occurrence of 3 or more continuous ventricular arrhythmia. The sympathetic nervous system has an important role in VA and is the target of treatment. Studies show that stellate ganglion blockade (SGB) can reduce cardiac sympathetic tone and is an alternative bridge therapy in VAs. In our study, the investigators preferred to apply a combination of local anesthetic and steroid in the stellate ganglion blocking method to 10 VA patients who were resistant to medical treatment and had an ICD, and we also planned to examine the 6-month follow-up results of the patients. In our study, USG-guided left stellate ganglion blockade was applied to 10 VA and ES patients with ICD. The 6-month results of the patients were evaluated retrospectively. For blockage, the solution was prepared by adding 8 mg dexamethasone, 40 mg lidocaine, and 10 mg bupivacaine to 10 mL with physiological saline. The success of the procedure was evaluated with the development of Horner's syndrome in the left eye.

NCT ID: NCT05640323 Completed - Healthy Clinical Trials

Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

Start date: April 26, 2023
Phase:
Study type: Observational

The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

NCT ID: NCT05563701 Completed - Heart Diseases Clinical Trials

Evaluation of the LVivo Image Quality Scoring (IQS)

Start date: September 5, 2022
Phase:
Study type: Observational

The study includes two parts: Part 1: - 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Each study includes 10 clips that represent typical user scanning errors - Offline evaluation of the system (by batch processing) shall be performed by comparing the system output to preliminary quality tagging by experienced sonographers Part 2: - Live scans of apical 4CH clips of patients with indication for POCUS examination will be performed by POC physicians - LVivo IQS shall be used (on Lumify) during the scan for patients that meet inclusion criteria until 50 exams will be collected. 3 sec of each scan shall be saved, and Image quality score (IQS) shall be documented - Saved scans shall be reviewed by an expert physician to determine whether they are clinically interpretable

NCT ID: NCT05505136 Completed - Cardiac Arrhythmia Clinical Trials

Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes

MAPS II
Start date: August 30, 2022
Phase:
Study type: Observational

To determine the associations among biometric data and previously reported medication changes in the original MAPS study

NCT ID: NCT05496504 Completed - Clinical trials for Pulmonary Hypertension

Pulmonary Hypertension and Arrhythmia

Start date: September 1, 2013
Phase:
Study type: Observational

Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias. Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).