High Intensity Focused Ultrasound (HIFU) Ablation System... | NCT00392106

ID	Type	Description	Link
NCT00392106

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

voluntarily by Sponsor to investigate an anticipated SAE

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Dec 2010Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Oct 24, 2006

First Submission Date that Met QC Criteria

Oct 24, 2006

First Posted Date

Oct 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2008

Last Update Posted Date

Jun 17, 2008Estimated

Description Module

Brief Summary

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator	Class I or III anti-arrhythmic drug for the treatment of AF	Drug: propafenone Drug: flecainide Drug: dofetilide Drug: sotolol Drug: Amiodarone
Treatment	Experimental	Pulmonary vein ablation with HIFU	Device: Pulmonary vein ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propafenone	Drug	Anti-arrhythmic drug prescribed for treatment of atrial fibrillation	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute treatment with elimination of AF episodes		12 months
Death, stroke, and hospitalization for recurrence of AF		within 12 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Acute treatment success		60 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Warren Jackman, MD	Oklahoma University Health Sciences Center	Principal Investigator
Hugh Calkins, MD	Johns Hopkins Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fullerton Vascular Medical Group		Fullerton	California	92835	United States
University of California, Los Angeles

ID	Term
D001281	Atrial Fibrillation
D001145	Arrhythmias, Cardiac

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011405	Propafenone
D005424	Flecainide
C063533	dofetilide
D013015	Sotalol
D000638	Amiodarone

Ancestor Terms

ID	Term
D011427	Propiophenones
D007659	Ketones
D009930	Organic Chemicals
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D000588	Amines
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring