Clinical Research Directory

Biofeedback Intervention for Paroxysmal Atrial Fibrillation

This project aims to bridge the gap between technology and healthcare by developing a biofeedback intervention that enables daily monitoring of atrial fibrillation episodes and physical activity levels. The main question it aims to answer is: Is a co-designed, usability-tested, bio-feedback intervention aimed at nudging patients with paroxysmal atrial fibrillation to increase physical activity feasible for a larger randomised control trial? The trial is split into two separate phases, each adopting different study designs, data collection, and data analysis methods. Phase 1 Co-design and usability testing: In this phase, we aim to test if smartwatches can be used to monitor AF and physical activity so that personalised atrial fibrillation-specific summaries can be created and sent to participants as text message nudges. The aim is to encourage participants to be more physically active. Participants will wear a smartwatch for 3 weeks, during which they will receive text messages giving them feedback on their atrial fibrillation and physical activity. After the 3 weeks, all participants will take part in a workshop to provide feedback on what they thought and what could be improved. Improvements will be implemented by the researchers, and the process will repeat for a total of two iterations. On the first iteration only, participants will also be asked to wear a Holter monitor OR chest strap and an additional smartwatch for the first 24 hours, alongside an accelerometer watch for the first 7 days. Phase 2 Feasibility study with embedded process evaluation: This phase aims to assess whether it is feasible and acceptable to run a larger trial across the UK (i.e. can the intervention be delivered properly and do patients think it is useful). Participants will be randomly allocated to either their normal standard of care, or to receive a smartwatch with the biofeedback messaging service in addition to their normal standard of care. The study will take 6 and a half months in total. Both groups will complete online questionnaires periodically over this period. Both groups will also need to wear a smartwatch and accelerometer watch for 7 days before and after testing.

P-wave Duration and Local Potential as Predictors of AF Recurrence Following Pulmonary Vein Isolation

Atrial fibrillation (AF) is the most prevalent sustained cardiac arrhythmia worldwide and is associated with substantial morbidity, mortality, and healthcare utilization. Catheter ablation, most commonly pulmonary vein isolation (PVI), is an established rhythm control strategy for AF4. Despite technological advances and the emergence of pulse field ablation (PFA), long-term AF recurrence after a first ablation procedure remains frequent, occurring in approximately 30-50% of patients5. Post-ablation follow-up strategies, including visit frequency, rhythm monitoring intensity, and Antiarrhythmic Drug management, vary widely across providers and institutions and are largely guided by subjective assessment rather than objective, science-based recurrence risk estimation6. In parallel, asymptomatic (silent) AF recurrence is exacerbated following ablation, limiting the reliability of symptom-driven follow-up7. FOLLOW-AF is a retrospective, observational cohort study designed to validate the FollowGenius algorithm and evaluate the diagnostic performance in predicting AF recurrence based on atrial remodeling and vein isolation. The cohort will be patients with paroxysmal or persistent AF who underwent PVI with the PFA modality.

3-Dimensional Mapping System: The PULSTAR II Study

\### Study Overview * Study Name In simple terms, this study involves using a new device to treat a heart condition called "Paroxysmal Atrial Fibrillation." * Sponsor The study is sponsored by a company called Shanghai Shangyang Medical Technology Co., Ltd. * Trial Devices The study will utilize two specialized devices: 1. \*\*Nanosecond Pulsed Electric Field Ablation Device\*\*: This device emits special electrical pulses to treat the heart. 2. \*\*Magnetoelectric Dual-Positioning Petal Pulse Ablation Catheter\*\*: This is a catheter that allows for precise navigation and treatment inside the heart. * Study Purpose The purpose of this study is to verify the safety and effectiveness of this new device in treating Paroxysmal Atrial Fibrillation, with the goal of enabling its widespread use in the future. * Study Design This is a prospective, multicenter, single-arm target value study. This means: * \*\*Prospective\*\*: The study looks forward in time, tracking patient outcomes. * \*\*Multicenter\*\*: The study is conducted simultaneously across multiple hospitals. * \*\*Single-Arm Target Value\*\*: All patients receive the same treatment, which is then compared against a predetermined target value. * Sample Size The study plans to enroll 149 patients. * Primary Endpoint The main goal of the study is to determine how many patients no longer experience atrial fibrillation, atrial flutter, or atrial tachycardia symptoms within 12 months after surgery. Specifically, it measures the proportion of patients who do not have arrhythmias lasting more than 30 seconds between 3 and 12 months post-surgery, as confirmed by electrocardiograms and other monitoring methods. * Secondary Endpoints The study also includes several secondary objectives: 1. \*\*Immediate Post-Surgical Ablation Success Rate\*\*: To check how many patients have their atrial fibrillation successfully "isolated" immediately after surgery. 2. \*\*Pulse Catheter Evaluation\*\*: To assess the performance and ablation parameters of the catheter. 3. \*\*Pulse Device Evaluation\*\*: To evaluate the software operability, operational stability, and hardware connectivity of the device. * Safety Indicators The study will also monitor the safety of the treatment, including: 1. \*\*Primary Safety Endpoint\*\*: The rate of adverse events occurring within 7 days after surgery. 2. \*\*Secondary Safety Endpoint\*\*: The incidence of device-related adverse events and serious adverse events. * Inclusion Criteria Only patients who meet the following criteria can participate in the study: 1. Age between 18 and 75 years. 2. Diagnosed with Paroxysmal Atrial Fibrillation. 3. Recurrent episodes with noticeable symptoms. 4. Documented atrial fibrillation on an electrocardiogram or Holter monitor within the past year. 5. Poor response or intolerance to at least one standard antiarrhythmic medication. 6. Willingness to sign an informed consent form and comply with all study-related tests and procedures. * Exclusion Criteria Patients with the following conditions cannot participate in the study: 1. Previous atrial fibrillation surgery. 2. Presence of left atrial thrombus. 3. Inability to use effective contraception during the 12-month study period. 4. Enlarged left atrium or other cardiac issues. 5. Severe systemic infections or other health problems. 6. Recent history of other serious diseases or surgeries. 7. Bleeding tendencies or other blood disorders. 8. Participation in other clinical trials within the past 3 months.

PREACTIVE: Preconditioning Exercise Intervention to Improve Symptoms and Quality of Life in Comorbid Atrial Fibrillation and HFpEF

Atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF) are very common conditions that often occur together and result in worsening symptoms and reduced quality of life (QoL). Limitations being able to participate in activities of daily living is a primary complaint for AF-HFpEF patients, yet effective strategies to address this issue remain limited. While exercise interventions targeting aerobic training (AT) are recommended for patients with AF and HFpEF, unique challenges exist in this patient population who tend to be older. Specifically, many older patients with AF and HFpEF have muscle weakness, sarcopenia and frailty, that can make aerobic-focused exercise difficult and less tolerable. This study proposes that starting with progressive resistance training (PRT) before aerobic exercise may overcome these issues by improving muscle strength, making AT more manageable, and leading to better health outcomes. The goal of this study is to assess whether a sequential exercise program, named 'PREACTIVE' improves how people feel, decrease the amount of symptoms, and their ability to participate in exercise and activities. This study will specifically test a sequenced exercise approach of resistance training followed by aerobic exercise to improve symptoms, and quality of life in AF-HFpEF.

ALPs Single ChambEr New Device Study

Prospective, non-randomized, multi-center, international study designed to evaluate the initial safety and performance of the ALPS leadless pacemaker when used in patients with bradycardia.

CPAP Therapy and Atrial Fibrillation Recurrence in OSA

Obstructive sleep apnea (OSA) is a major modifiable risk factor for atrial fibrillation (AF). Continuous positive airway pressure (CPAP) therapy has been shown to improve cardiovascular outcomes; however, real-world data on its effect on AF recurrence remain limited. This prospective cohort study aims to evaluate the association between objective CPAP adherence and the risk of AF recurrence in patients with moderate-to-severe OSA and a history of paroxysmal AF. Patients will be followed for 12 months, with AF recurrence assessed using electrocardiography and Holter monitoring.

The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrythmia, associated with increased risk of stroke, heart failure, reduced quality of life (QoL), and psychological distress. This randomized controlled trial investigates the effect of MediYoga - a program incorporating deep breathing, low-intensity yoga, and meditation- on disease-specific QoL, blood pressure, and heart rate in 456 patients with paroxysmal AF. With a strong focus on sustainability, the study is fully digital: participants are recruited online, and the 12-week intervention is delivered through an application to smartphone. Additionally, the participants receive online support via Teams. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is disease specific QoL; secondary outcomes include blood pressure, heart rate, generic QoL, and psychological wellbeing. Qualitative interviews will explore patients' experiences with the intervention.

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is: Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment? Participants will: * Be given daily random assignments to avoid or not to avoid alcohol * Wear an adhesive electrocardiographic (ECG) heart monitor * Wear a wrist-worn fitness tracker * Wear an anklet transdermal alcohol monitor * Wear an adhesive glucose monitor * Complete morning and evening surveys daily Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF

This is a prospective, single-arm First-in-Human study to demonstrate the safety and effectiveness of the CardioFocus OptiShot Pulsed Field Ablation System for catheter ablation of atrial fibrillation (AF). Patients with symptomatic paroxysmal (short-duration) AF who have not had a previous catheter ablation for AF will be considered for the study. Patients will be followed for one year after the initial ablation procedure.

Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation

Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes. PFA has demonstrated a high safety profile with reduced complication rates compared to thermal ablation. Thermal ablation of parasympathetic ganglia during conventional pulmonary vein isolation (PVI) may improve long-term procedural outcomes by reducing AF recurrence. However, due to its non-thermal nature, PFA may not significantly affect cardiac autonomic innervation, which could be clinically relevant in vagally mediated AF or tachycardia-bradycardia syndrome. This randomized study compares two strategies: (1) PFA-only PVI, and (2) PFA combined with selective thermal ablation (radiofrequency energy) of the superior paraseptal parasympathetic ganglion. The primary objective is to evaluate whether adjunctive thermal ablation improves clinical outcomes and reduces intraprocedural bradyarrhythmic events.

A Study Evaluating the Effectiveness and Safety of Pulsed Field Ablation Using the FARAPULSE™ System for Electrical Isolation of Pulmonary Veins and Superior Vena Cava

This study is a prospective, single-center, single-arm clinical trial planning to screen and enroll 200 subjects. It aims to evaluate the efficacy and safety of pulsed field ablation (PFA) using the FARAPULSE™ system for pulmonary vein isolation (PVI) and superior vena cava isolation (SVCI) in Chinese patients with paroxysmal atrial fibrillation (PAF). Baseline preoperative data, along with intraoperative and postoperative follow-up information, will be collected. The primary endpoint is the proportion of subjects achieving successful PVI and SVCI using solely the FARAPULSE™ PFA system. Secondary endpoints include long-term procedural success rates and various procedural parameters. Additionally, the incidence of adverse events will be recorded as safety endpoints. The study adopts a single-arm target value design hypothesis, and research data will also be compared with historical data from patients treated with radiofrequency ablation for PVI and SVCI to further evaluate the efficacy of PFA. Subgroup analysis will be conducted in patients with heart failure to assess the efficacy and safety of PFA in this population.

Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)

The WIDER PVI study is a multicentre randomized clinical trial to compare the efficacy of antral versus extended antral PVI in patients with paroxysmal or persistent AF undergoing this procedure using a cryoablation balloon capable of 28 mm diameter (antral isolation) or 31 mm diameter (extended antral isolation) applications. The aim is to evaluate an objective of superiority of the extended antral isolation strategy versus antral isolation in the recurrence of atrial tachyarrhythmias at 1-year follow-up, both in episodes of \>30 seconds duration and in overall arrhythmic load.