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Arrhythmias, Cardiac clinical trials

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NCT ID: NCT06452589 Not yet recruiting - Atrial Arrhythmias Clinical Trials

The Field PULSE Study

Start date: July 2024
Phase: N/A
Study type: Interventional

This is a pre-market, first-in-human, pilot, interventional, clinical investigation that aims to evaluate safety and feasibility of the FieldForce™ Ablation system in patients with atrial fibrillation who are indicated for an AF catheter ablation.

NCT ID: NCT06425887 Not yet recruiting - Arrythmia Clinical Trials

Smartwatch Paroxysmal Arrhythmia Detection Compared With Holter

Start date: July 1, 2024
Phase:
Study type: Observational

The lifetime risk for development of atrial fibrillation, the commonest sustained arrhythmia in adults, is estimated to be 24%-27% for individuals of 40 years or older. Previous work showed that annual new diagnosis of AF is 11000-26000 in Hong Kong. Other arrhythmia such as supraventricular arrhythmia or premature beats were also common and of clinical significance. 12-lead ECG is a first line investigation for patients with suspected paroxysmal arrhythmia, but it has a low diagnostic yield with its 10-30 seconds recordings. 24-hour Holter exam is the usual next step of diagnosis. The diagnostic yield of Holter varies according to indication but is generally low at 1%-12%. This is because paroxysmal arrhythmia may not happen every day. In addition, even if arrhythmia is picked up in Holter, patient may not register the symptom, making the symptom arrhythmia correlation problematic. Despite limitations, the demand for Holter exam is still high. In Prince of Wales Hospital, a tertiary referral centre with a catchment of about 1 million populations, the waiting time for a routine Holter exam is 3 years. Smartwatch has gained popularity over past years as an adjunct to smartphone. Latest generations of smartwatch were equipped with wearer-initiated ECG rhythm strip recording capabilities. Smartwatch has evolved to become a health tracker with arrhythmia detection capabilities. It was found to be a useful tool for atrial fibrillation screening in general population. Other arrhythmias, such as supraventricular tachycardia, premature beats, and abnormal ECG patterns associated with sudden cardiac death could also be detected with smartwatch ECG recordings. Apple Heart study was the largest study utilizing smartwatch for arrhythmia detection. The general population was screened for atrial fibrillation using irregular pulse algorithm. The study found a 84% concordance rate between irregular pulse notification and ECG patches. Therefore, investigators propose to conduct a study to compare its diagnostic yield with Holter, in patients with suspected arrhythmia and see if smartwatch recording following a systematic protocol for four-weeks will have better arrhythmia diagnosis yield than a 24-hour Holter exam.

NCT ID: NCT06414447 Not yet recruiting - Arrythmia Clinical Trials

Electrocardiogram (ECG) Validation Study

Start date: May 2024
Phase:
Study type: Observational

Comparison of diagnostic Electrocardiogram (ECG) signals

NCT ID: NCT06384963 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

RSA-PACE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: - Is the new type of pacemaker safe? - Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.

NCT ID: NCT06360939 Not yet recruiting - Clinical trials for Ventricular Tachycardia

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

Radioablate
Start date: May 20, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are: - What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months - What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).

NCT ID: NCT06359938 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

RSA-PACE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: - Is the new type of pacemaker safe? - Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.

NCT ID: NCT06358391 Not yet recruiting - Atrial Fibrillation Clinical Trials

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

NCT ID: NCT06351956 Not yet recruiting - Cardiac Arrhythmia Clinical Trials

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.

Start date: April 20, 2024
Phase:
Study type: Observational

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes

NCT ID: NCT06344494 Not yet recruiting - Atrial Fibrillation Clinical Trials

Cardiac Interventional ICE Imaging Trial

INTELICE
Start date: May 2024
Phase: N/A
Study type: Interventional

The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.

NCT ID: NCT06165510 Not yet recruiting - Clinical trials for Persistent Atrial Fibrillation

Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

CLIP-AF
Start date: January 2024
Phase: N/A
Study type: Interventional

A randomised controlled clinical trial to assess efficacy of convergent ablation with the LARIAT procedure, as compared to standard endocardial catheter ablation in patients with long-standing persistent atrial fibrillation (AF).