Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD

Status Completed

Clinical Trial Summary

The purpose of this prospective randomized controlled study is to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted magnetic resonance imaging technique.

Clinical Trial Description

Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is associated with the occurrence of procedure-related thromboembolic events, especially the risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an increasingly used technique for catheter ablation of AF, which is proposed to be associated with relatively wider and superficial lesions, less risk of esophageal injury, and shorter procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip irrigation system, which is a wide-spread distribution of the irrigating solution (56 irrigation holes), resulting in homogenous cooling and protection from thrombus formation and reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04408716
Study type	Interventional
Source	The Second Affiliated Hospital of Chongqing Medical University
Contact
Status	Completed
Phase	N/A
Start date	June 17, 2020
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Completed	`NCT04571385` - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)	Phase 2
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Completed	`NCT05366803` - Women's Health Initiative Silent Atrial Fibrillation Recording Study	N/A
Completed	`NCT02864758` - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting	`NCT05442203` - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease	N/A
Completed	`NCT05599308` - Evaluation of Blood Pressure Monitor With AFib Screening Feature	N/A
Completed	`NCT03790917` - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation	`NCT05890274` - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO	N/A
Recruiting	`NCT05266144` - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting	`NCT05316870` - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation	N/A
Not yet recruiting	`NCT06023784` - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT04087122` - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures	N/A
Completed	`NCT06283654` - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04546763` - Study Watch AF Detection At Home
Completed	`NCT03761394` - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms