Substrate Versus Trigger Ablation for Paroxysmal Atrial Fibrillation

Status unconfirmed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

This is a prospective randomized study to assess the safety and efficacy of FIRM (Focal Impulse and Rotor Modulation)-guided ablation for the treatment of symptomatic atrial fibrillation (AF). The study hypothesis is that the efficacy of AF elimination at 1 year will be higher by ablating patient-specific AF-sustaining rotors and focal sources by Focal Impulse and Rotor Modulation (FIRM) compared to conventional ablation alone (wide-area PV isolation).

Key facts

Study ID

NCT02169037

Run by

University of California, San Diego

People needed

120

Starts

2016-02-01

Expected to finish

2022-07-01

Last updated by the study team

2021-06-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male or female >21 years
• reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the three months preceding trial entry (at least 1 episode documented by 12-lead ECG or ECG rhythm strip)
• women without childbearing potential or women of childbearing potential who are not pregnant per a serum HCG test
• refractory to at least one Class I or III anti-arrhythmic medications. Drug doses must be therapeutic and stable
• willingness, ability and commitment to participate in baseline and follow-up evaluations without participation in another clinical trial (unless documented approval received from both sponsors)
• oral anticoagulation required for those subjects who have a score of two or more based on the following criteria (CHAD score):
• Congestive heart failure (1 point)
• hypertention (1 point)
• age 75 years or older (2 points)
• diabetes (1 point)
• prior stroke or transient ischemic attack (2 points)
• vascular disease (1 point)
• age 65 years or older (1 point)
• sex category: female (1 point)
• patient is willing and able to remain on anti-coagulation therapy for a minimum of 3 months post procedure for all subjects, and potentially indefinitely post procedure if the patient has CHAD score >or=2
• signed informed consent after a full discussion of the risks and benefits of both therapy arms, and the concept of randomization
• NYHA Class 0,I, II stable on medical therapy for > 3months
• left atrial diameter <or= 5.5cm
• LVEF >or=40%
• sustained AF during the procedure

You may not qualify if…

• atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, pericarditis)
• cardiac or thoracic surgery within the past 180 days
• AF secondary to electrolyte imbalance, thyroid disease
• contraindication to Heparin
• Contraindication to Warfarin or other novel oral anticoagulants
• history of significant bleeding abnormalities
• history of significant blood clotting abnormalities, systemic thrombi or systemic embolization
• ASD closure device, LAA closure device, prosthetic mitral or tricuspid valve
• atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) within 72 hours of the procedure
• intramural thrombus or other cardiac mass that may adversely effect catheter introduction or manipulation
• significant pulmonary embolus within 6 months of enrollment
• acute illness or active systemic infection or sepsis that may ordinarily warrant postponement of the procedure
• history of recent cerebrovascular disease (stroke or TIA) or systemic thromboembolism within < 6 months
• NYHA classes III, IV
• heart failure that is not stable on medical therapy
• pulmonary edema, that may make planned anesthesia or sedation difficult
• stable/unstable angina or ongoing myocardial ischemia
• myocardial infarction (MI) within the past three months
• structural heart disease of clinical significance including:
• congenital heart disease where the abnormality or its correction prohibit or increase the risk of ablation
• acquired heart disease that may increase risk of ablation, such as significant ventricular septal defect post myocardial infarction
• rheumatic valve disease, since this produces a unique AF phenotype
• extreme left atrial enlargement (LA volume index > 60 ml/m2) in whom PVI has low success and 55 mm baskets are too small for the atria
• cardiac transplantation or other cardiac surgery planned within the 12 month followup period of the trial
• life expectancy less than 12 months (the followup period of the trial)

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)
• VA San Diego Medical Center — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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