Radiofrequency Ablation for Atrial Fibrillation
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohad Ziv
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:
1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
2. an approach of pulmonary vein isolation (PVI) alone.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since participants must have failed or been intolerant to at least one antiarrhythmic drug, it's possible that some medication changes might be necessary. Please consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Radiofrequency Ablation for Atrial Fibrillation?
Research suggests that targeting low-voltage areas during catheter ablation can reduce the recurrence of atrial fibrillation, making it a promising strategy for treating persistent atrial fibrillation.
12345Is radiofrequency ablation for atrial fibrillation generally safe for humans?
Radiofrequency ablation for atrial fibrillation is considered a safe treatment for heart rhythm problems, but it does carry some risks. Complications can occur, such as issues with blood vessels or the heart's structure, and these risks are higher compared to other heart procedures. However, improvements in techniques have reduced these risks over time.
678910How is Low Voltage-Directed Catheter Ablation different from other treatments for atrial fibrillation?
Low Voltage-Directed Catheter Ablation is unique because it targets specific low-voltage areas in the heart, which may improve outcomes for patients with persistent atrial fibrillation by addressing areas that contribute to the arrhythmia, unlike standard ablation that primarily focuses on isolating the pulmonary veins.
23111213Eligibility Criteria
This trial is for adults aged 18-85 with non-paroxysmal atrial fibrillation who've had a bad reaction or no success with at least one antiarrhythmic drug and are scheduled for an AF ablation procedure. They must not have severe heart issues, recent strokes, or be pregnant, among other exclusions.Inclusion Criteria
I have tried at least one heart rhythm medication that didn't work or caused side effects.
I am between 18 and 85 years old.
I have a type of irregular heartbeat that doesn't come and go.
My heart's left atrium showed low voltage during a mapping procedure.
Exclusion Criteria
I have had a procedure to correct irregular heartbeats on the left side of my heart.
I do not have severe or uncontrolled heart failure.
I have had atrial fibrillation for at least 1 year.
I have a heart valve problem that is not stable.
I have had a heart attack or bypass surgery in the last 3 months.
I have had a blood clot within the last 6 months.
I cannot use a heart monitoring device or wear a Holter monitor for 4 weeks.
I cannot take blood thinners due to health reasons.
I have severe high blood pressure in the lungs.
Participant Groups
The study compares two techniques to treat atrial fibrillation: one combines low voltage-directed ablation with pulmonary vein isolation (LD+PVI), while the other uses only pulmonary vein isolation (PVI).
2Treatment groups
Active Control
Group I: PVI+Total LT Atrial low voltage ablationActive Control1 Intervention
PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.
Group II: Pulmonary vein isolation (PVI) aloneActive Control1 Intervention
Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..
Low Voltage-Directed Catheter Ablation is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Low Voltage-Directed Catheter Ablation for:
- Atrial Fibrillation
🇪🇺 Approved in European Union as Low Voltage-Directed Catheter Ablation for:
- Atrial Fibrillation
🇨🇦 Approved in Canada as Low Voltage-Directed Catheter Ablation for:
- Atrial Fibrillation
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
MetroHealth Medical CenterCleveland, OH
Loading ...
Who is running the clinical trial?
Ohad ZivLead Sponsor
Biosense Webster, Inc.Industry Sponsor
References
Pre-procedural predictors of left atrial low-voltage zones in patients undergoing catheter ablation of atrial fibrillation. [2022]Pulmonary vein isolation has become a cornerstone treatment for catheter ablation of atrial fibrillation (AF). Recent reports show that additional ablation targeting low-voltage zones reduces AF recurrence. However, the pre-procedural predictors of low-voltage zones remain elusive. We retrospectively enrolled 359 patients (mean age 63.7 ± 10.8 years; 73 females; and 149 had persistent atrial fibrillation) who underwent catheter ablation for AF and left atrial (LA) voltage mapping during sinus rhythm or atrial pacing. Low-voltage zones were defined as area of > 5 cm2 with a bipolar electrogram amplitude of
Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale. [2022]Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF.
Left atrial function and scar after catheter ablation of atrial fibrillation. [2016]Catheter ablation of atrial fibrillation (AF) involves extensive radiofrequency ablation (RFA) of the left atrium (LA) around the pulmonary veins. The effect of this therapy on LA function is not fully characterized.
Comparison of Left Atrial Voltage between Sinus Rhythm and Atrial Fibrillation in Association with Electrogram Waveform. [2018]The efficacy of low-voltage-guided ablation in addition to pulmonary vein (PV) isolation for atrial fibrillation (AF) has been reported with voltage mapping being performed during sinus rhythm (SR) or AF. The study aimed to compare the left atrial voltage between SR and AF in association with the electrogram waveform.
Catheter ablation of atrial fibrillation in patients with heart failure with reduced ejection fraction: Real world experience from six European centers. [2020]Catheter ablation of atrial fibrillation (AF) has been recently shown to have an impact on the outcome of patients with heart failure and reduced LV ejection fraction (LVEF). We aimed to assess patients with reduced LVEF referred to catheter ablation of AF, and the efficacy and safety of this procedure compared with healthier patients.
Early complications of pulmonary vein catheter ablation for atrial fibrillation: a multicenter prospective registry on procedural safety. [2016]Data on the procedural safety of pulmonary vein radiofrequency catheter ablation for atrial fibrillation (AF) are as yet scant.
Safety and complications of catheter ablation for atrial fibrillation: Predictors of complications from an updated analysis the National Inpatient Database. [2022]Catheter ablation is increasingly employed in the management of atrial fibrillation (AF). Data regarding safety of ablation of AF is largely derived from controlled clinical trials.
Management of patients pre-, per- and postcatheter ablation procedures: how to minimize complications? [2011]Catheter ablation using radiofrequency energy has become an accepted and safe treatment of cardiac arrhythmias. Nevertheless, it is important to determine the risk-to-benefit ratio of a specific procedure, especially when treating subjects with non-life-threatening cardiac arrhythmias, such as AV-nodal reentrant tachycardia or atrial fibrillation, and efforts have to be made to reduce the incidence of complications associated with these procedures, which are in the vast majority of cases not directly attributable to RF energy application but rather with obtaining peripheral vascular access or intracardiac catheter manipulation. Although complication rates in atrial fibrillation (AF) ablation have decreased with improvements of the ablation technique and a change of ablation concepts since the introduction of this technique, the risk of complication is still considerable and significantly higher compared to ablation procedures of other supraventricular tachycardia, including potentially life-threatening events. The higher incidence of AF ablation associated complications may be explained by the complex technique, the need for trans-septal puncture or extensive manipulation in the thin walled left atrium, as well as possible adverse effects of sedation. Even "new" complications associated with AF catheter ablation were identified, such as pulmonary vein stenosis or atrio-esophageal fistula formation. This article will review general risks and complications that can occur during RF catheter ablation procedures and conscious sedation with a particular attention on AF ablation procedures.
[Nightmares in atrial fibrillation ablation--identification, management, and prevention of complications in radiofrequency ablation of atrial fibrillation]. [2021]Radiofrequency ablation is increasingly being established as a curative treatment option for atrial fibrillation refractory to antiarrhythmic drug therapy. Especially catheter ablation of atrial fibrillation is associated with significant procedure-related risks, as this is one of the most complex interventional electrophysiologic procedures. Knowledge about common and infrequent complications, incidence, etiology, and techniques for prevention should minimize risk and help to further increase procedural success. This paper intends to provide a practice-oriented summary of international surveys and consensus documents in comparison with data from our own electrophysiologic laboratory. Great attention will be laid upon early recognition and technical as well as procedure-related possibilities to prevent any complication.
Catheter ablation for atrial fibrillation in a low-volume center using contemporary technology. [2022]Catheter ablation is increasingly being performed worldwide for atrial fibrillation (AF). However, there are concerns of lower success rates and higher complications of AF ablations performed in low-volume centers. Thus, we sought to evaluate the safety and efficacy of AF catheter ablation in a low-volume center using contemporary technologies.
Echocardiographic assessment in patients with atrial fibrillation (AF) and normal systolic left ventricular function before and after catheter ablation: If AF begets AF, does pulmonary vein isolation terminate the vicious circle? [2021]Radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) can be curative. There are conflicting data on whether AF associated atrial and ventricular structural remodeling reverses after ablation. The aim of this study was to evaluate the hemodynamic effect of AF ablation in patients with preserved left ventricular ejection fraction (LVEF).
Reduction of fluoroscopy exposure and procedure duration during ablation of atrial fibrillation using a novel anatomical navigation system. [2022]Catheter ablation of atrial fibrillation (AF) is centred on pulmonary vein (PV) ablation with or without additional atrial substrate modification. These procedures may be prolonged with significant fluoroscopy exposure. This study evaluates a new non-fluoroscopic navigation system during ablation of AF.
Low-voltage area substrate modification for atrial fibrillation ablation: a systematic review and meta-analysis of clinical trials. [2022]The value of additional ablation beyond pulmonary vein isolation for atrial fibrillation (AF) ablation is unclear, especially for persistent AF. The optimal target for substrate modification to improve outcomes is uncertain. We investigate the utility of low-voltage area (LVA) substrate modification in patients undergoing catheter ablation for AF.