High Intensity Focused Ultrasound (HIFU) Ablation System Study

This study has suspended participant recruitment.
(voluntarily by Sponsor to investigate an anticipated SAE)
Sponsor:
Information provided by:
ProRhythm, Inc.
ClinicalTrials.gov Identifier:
NCT00392106
First received: October 24, 2006
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: propafenone
Drug: flecainide
Drug: dofetilide
Drug: sotolol
Device: Pulmonary vein ablation
Drug: Amiodarone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by ProRhythm, Inc.:

Primary Outcome Measures:
  • Acute treatment with elimination of AF episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Death, stroke, and hospitalization for recurrence of AF [ Time Frame: within 12 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute treatment success [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Class I or III anti-arrhythmic drug for the treatment of AF
Drug: propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Other Name: Rhyhmol
Drug: flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
Other Name: Tambocor
Drug: dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Other Name: Tikosyn
Drug: sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Other Name: Betapace
Drug: Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
Other Name: Pacerone
Experimental: Treatment
Pulmonary vein ablation with HIFU
Device: Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
Other Name: Left atrial ablation

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392106

  Show 21 Study Locations
Sponsors and Collaborators
ProRhythm, Inc.
Investigators
Principal Investigator: Warren Jackman, MD Oklahoma University Health Sciences Center
Principal Investigator: Hugh Calkins, MD Johns Hopkins Medical Center
  More Information

No publications provided

Responsible Party: Reinhard Warnking, President and CEO, ProRhythm, Inc.
ClinicalTrials.gov Identifier: NCT00392106     History of Changes
Other Study ID Numbers: CLIN-003
Study First Received: October 24, 2006
Last Updated: June 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ProRhythm, Inc.:
atrial fibrillation
arrhythmia
AF ablation
antiarrhythmic agent
catheter ablation
pulmonary veins

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014