Ablation Techniques for Atrial Fibrillation
(RECONFIRM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen bySanjiv Narayan, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Stanford University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial compares two methods of treating atrial fibrillation: one using a special technique to find specific problem areas in the heart and one without it. It targets patients whose condition hasn't improved with medication. The special technique aims to make the treatment more precise and effective.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be refractory to at least one Class I or III anti-arrhythmic medication, and your drug doses must be therapeutic and stable. You also need to be on oral anticoagulation if your CHA2DS2VASc score is two or more, and you must remain on anticoagulation therapy for at least 3 months post-procedure.
What data supports the idea that Ablation Techniques for Atrial Fibrillation is an effective treatment?
The available research shows that Ablation Techniques for Atrial Fibrillation, such as Pulmonary Vein Isolation (PVI) and Focal Impulse and Rotor Modulation (FIRM)-guided ablation, are effective treatments. Studies indicate that PVI is considered the standard method for treating atrial fibrillation, and adding FIRM-guided ablation can further reduce the recurrence of irregular heartbeats. Some research suggests that FIRM-guided ablation alone or combined with PVI can be more effective than PVI alone in certain cases. Additionally, these techniques have been compared to other methods like cryoballoon PVI, showing similar or improved outcomes in managing atrial fibrillation.
12345What safety data exists for ablation techniques for atrial fibrillation?
The provided research does not contain specific safety data for ablation techniques for atrial fibrillation, such as Pulmonary Vein Isolation (PVI) or Catheter Ablation. The studies mentioned focus on different aspects, such as the effectiveness of catheter ablation in young adults and the potential benefits of additional cavotricuspid isthmus ablation. For comprehensive safety data, it would be necessary to consult clinical trial results or reviews specifically addressing the safety of these ablation techniques.
678910Is the treatment FIRM-guided ablation plus PVI a promising treatment for atrial fibrillation?
Yes, FIRM-guided ablation plus PVI is a promising treatment for atrial fibrillation because it combines the standard method of isolating pulmonary veins with a new technique that targets specific areas in the heart, potentially improving the success of the treatment.
12111213Eligibility Criteria
Adults over 21 with symptomatic atrial fibrillation, stable on medical therapy for 3+ months, and a left atrial diameter ≤5.5cm. Must have had at least two episodes of AF in the last three months and be refractory to one anti-arrhythmic medication. Participants need to agree to anticoagulation post-procedure and not be pregnant or planning pregnancy.Inclusion Criteria
I am older than 21 years.
Your heart's pumping function is at least 40%.
I have had at least two episodes of AF in the last 3 months, confirmed by an ECG.
+10 more
Exclusion Criteria
I have had a heart attack in the last 3 months or have ongoing heart issues.
You are not expected to live for at least 12 months, which is the length of the trial.
I have not had a stroke, TIA, or blood clot in the last 6 months.
+12 more
Participant Groups
The study is testing if adding FIRM (Focal Impulse and Rotor Modulation) to conventional PVI (Pulmonary Vein Isolation) is safer and more effective for treating atrial fibrillation than PVI alone. Patients are randomly assigned to either treatment group.
2Treatment groups
Experimental Treatment
Active Control
Group I: FIRM-guided ablation plus PVIExperimental Treatment1 Intervention
These patients will be treated by ablation of patient-specific rotors and focal sources (FIRM). Conventional ablation (PVI) will then be performed as part of the standard of care procedure.
Group II: Conventional AF Ablation with PVIActive Control1 Intervention
These patients will be treated by conventional AF ablation by pulmonary vein isolation (PVI) alone.
Conventional AF Ablation with PVI is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Pulmonary Vein Isolation for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
🇺🇸 Approved in United States as Pulmonary Vein Isolation for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
🇨🇦 Approved in Canada as Pulmonary Vein Isolation for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
🇯🇵 Approved in Japan as Pulmonary Vein Isolation for:
- Symptomatic atrial fibrillation
- Paroxysmal atrial fibrillation
- Persistent atrial fibrillation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Veterans Affairs Medical CenterSan Diego, CA
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study. [2022]Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. Recently, catheter ablation targeting rotors or focal sources has been developed for treatment of AF. This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM)-guided ablation as the sole ablative strategy with PVI in patients with paroxysmal AF.
Focal impulse and rotor modulation guided ablation versus pulmonary vein isolation for atrial fibrillation: A meta-analysis of head-to-head comparative studies. [2021]Empirical pulmonary vein isolation (PVI) remains the cornerstone for catheter ablation of atrial fibrillation (AF). Various ablation strategies and modalities are continually tested with the aim of improving ablation outcomes. Although focal impulse and rotor modulation (FIRM)-guided ablation is currently used as an adjunct to PVI, evidence supporting this strategy is conflicting. We sought to examine whether the utilization of FIRM-guided ablation with or without PVI is associated with a decrease in all-atrial arrhythmia recurrence as compared to PVI alone.
Cost effectiveness of focal impulse and rotor modulation guided ablation added to pulmonary vein isolation for atrial fibrillation. [2019]Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed.
Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation. [2022]Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF.
Impact of Rotor Ablation in Nonparoxysmal Atrial Fibrillation Patients: Results From the Randomized OASIS Trial. [2017]Nonrandomized studies have reported focal impulse and rotor modulation (FIRM)-guided ablation to be superior to pulmonary vein antrum isolation (PVAI) for persistent atrial fibrillation and long-standing persistent atrial fibrillation.
Additional cavotricuspid isthmus ablation may reduce recurrent atrial tachyarrhythmia after total thoracoscopic ablation for persistent atrial fibrillation. [2019]Unlike catheter ablation, little is known about the benefits of cavotricuspid isthmus (CTI) ablation in total thoracoscopic ablation (TTA) of atrial fibrillation (AF). This study aimed to investigate the incidence of recurrent atrial tachyarrhythmia (ATa) according to additional CTI ablation after TTA in patients with persistent AF.
Catheter ablation for lone atrial fibrillation in individuals aged under 35 years. [2019]To assess the effectiveness of radiofrequency catheter ablation for lone atrial fibrillation in young adults.
Posterior ankle impingement syndrome: MR imaging findings in seven patients. [2006]To report the magnetic resonance (MR) imaging findings in seven patients with posterior ankle impingement (PAI) syndrome.
Increased signal of the fibular collateral ligament of the knee on MRI, clinically significant? [2023]The purpose of this study was to determine the clinical significance of signal hyperintensity in the proximal fibular collateral ligament (FCL) on coronal proton density (PD) fat-saturated (FS) MRI of the knee, a common finding. This study is unique in that it characterizes the FCL of a comprehensive, large cohort of both symptomatic and asymptomatic patients, which to our knowledge represents the first study with such broad inclusion criteria.
Increased Accuracy of Varus Stress Radiographs Versus Magnetic Resonance Imaging in Diagnosing Fibular Collateral Ligament Grade III Tears. [2019]To evaluate the diagnostic accuracy of magnetic resonance imaging and varus stress radiographs for fibular collateral ligament (FCL) tears, and compare these modalities to intraoperative findings.
Radiofrequency Ablation of Atrial Fibrillation: Nonrandomized Comparison of Circular versus Point-by-Point "Smart" Ablation for Achieving Circumferential Pulmonary Vein Isolation and Curing Arrhythmic Symptoms. [2022]Pulmonary vein isolation (PVI) with radiofrequency (RF) ablation is now standard care for atrial fibrillation (AF). New improvements in PVI techniques include use of catheters that measure contact-force and circular ablation catheters. These techniques have not been compared.
Comparative effectiveness of catheter ablation strategies for rhythm control in patients with atrial fibrillation: a meta-analysis. [2021]Pulmonary vein isolation (PVI) forms the basis of catheter ablation strategies for atrial fibrillation (AF). Ablation of additional sites has been used to increase the efficacy of ablation procedures in restoring and maintaining normal sinus rhythm.
Pulmonary vein isolation plus adjunctive therapy for the treatment of atrial fibrillation: a systematic review and meta-analysis. [2023]Pulmonary vein isolation (PVI) is the primary technique for ablation of atrial fibrillation (AF). It is unclear whether adjunctive therapies in addition to PVI can reduce atrial arrhythmia recurrence (AAR) compared to PVI alone in patients with AF.