High Intensity Focused Ultrasound (HIFU) Ablation System Study

ProRhythm, Inc.

Status and phase: Suspended; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: sotolol; Drug: propafenone; Drug: dofetilide; Drug: Amiodarone; Drug: flecainide; Device: Pulmonary vein ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392106

CLIN-003

NCT00392106

Details and patient eligibility

About

The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.

Full description

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.

Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.

Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented atrial fibrillation
• Failed or intolerant to at least 1 anti-arrhythmic drug
• Able to take anti-coagulant therapy
• Able to complete screening tests required for inclusion/exclusion criteria
• Able to take at least 1 approved anti-arrhythmic drug
• Not pregnant
• Available for follow-up for at least 12 months

Exclusion criteria

• Persistent or permanent atrial fibrillation
• Mitral disease
• Prior surgical treatment for atrial fibrillation
• Ablation for treatment of atrial fibrillation within 6 months
• Severe left ventricular hypertrophy
• Known untreated coagulopathy
• Unstable angina
• Prior stroke
• Uncontrolled heart failure
• Secondary causes of atrial fibrillation
• Uncorrected hyperthyroidism within 12 months
• Pulmonary embolism within 6 months
• Pneumonia or acute pulmonary disease within 3 months
• Pacemaker/ICD
• High risk for esophageal disease
• Currently enrolled in investigational drug or device study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Control

Active Comparator group

Description:

Class I or III anti-arrhythmic drug for the treatment of AF

Treatment:

Drug: Amiodarone

Drug: flecainide

Drug: dofetilide

Drug: sotolol

Drug: propafenone

Treatment

Experimental group

Description:

Pulmonary vein ablation with HIFU

Treatment:

Device: Pulmonary vein ablation