Clinical trialNCT00392106SuspendedPhase 3Interventional

High Intensity Focused Ultrasound (HIFU) Ablation System Study

SponsorProRhythm, Inc.Enrollment240Atrial Fibrillation

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Hugh Calkins, MD
Johns Hopkins Medical Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Warren Jackman, MD
Oklahoma University Health Sciences Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

21 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Czechia

Homolka Hospital
Prague, Czechia

United States

Fullerton Vascular Medical Group
Fullerton, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Piedmont Hospital
Atlanta, Georgia, United States
Lexington Central Baptist Hospital
Lexington, Kentucky, United States
Johns Hopkins Hopsital
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
Beaumont Hospital
Royal Oak, Michigan, United States
New York University Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Wake Forest University Health Systems
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Hospital
Cleveland, Ohio, United States
the Ohio State University Heart Center
Columbus, Ohio, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
University of Texas, Southwestern
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Amiodarone →Dofetilide →Flecainide →Propafenone →Sotolol

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Apr 2006
Primary completion: 31 Dec 2010
Completion: 30 Jun 2011
Last update posted: 17 Jun 2008
Registered enrollment: 240
Registry id: NCT00392106

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.