NCT01997736

Brief Summary

The purpose of this study is to collect preliminary safety and effectiveness data evaluating the Toray Satake Balloon Thermal Ablation System (TSB)to treat subjects with symptomatic paroxysmal atrial fibrillation that is resistant to antiarrhythmic drug therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

November 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 6, 2019

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

November 8, 2013

Last Update Submit

September 3, 2019

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Paroxysmal Atrial FibrillationCatheter AblationAblation Techniques

Outcome Measures

Primary Outcomes (1)

  • Occurrence of major complications

    6 months

Study Arms (1)

Ablation

EXPERIMENTAL
Device: Ablation

Interventions

AblationDEVICE
Also known as: Toray Satake Balloon Thermal Ablation System
Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation
  • ≥2 Symptomatic atrial fibrillation episodes
  • At least 1 paroxysmal atrial fibrillation episode documented by an ECG or device recording system in the 6 months prior to enrollment AND
  • At least 1 additional (for a total of ≥2) paroxysmal atrial fibrillation episode documented by an ECG or device recording system, OR, at a minimum, a physician's note indicating recurrent symptomatic atrial fibrillation
  • No episode \>7 days
  • Failed to respond to or is intolerant of ≥1 Class I, II, III or IV antiarrhythmic drug
  • Able and willing to provide informed consent and Health Insurance Privacy and Portability Act (HIPAA) authorization
  • Able and willing to meet all study requirements, including attending all post-ablation procedure assessments and visits

You may not qualify if:

  • Left atrium ≥50 mm
  • Chronically used amiodarone in the 3 months prior to enrollment
  • Previous left atrial ablation or surgical treatment for atrial fibrillation
  • Left ventricular ejection fraction (LVEF) \<35 %
  • New York Heart Association (NYHA) Class III or IV heart failure
  • History of myocardial infarction (MI) or unstable angina in the 6 months prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

William Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Related Publications (4)

  • Satake S, Tanaka K, Saito S, Tanaka S, Sohara H, Hiroe Y, Miyashita Y, Takahashi S, Murakami M, Watanabe Y. Usefulness of a new radiofrequency thermal balloon catheter for pulmonary vein isolation: a new device for treatment of atrial fibrillation. J Cardiovasc Electrophysiol. 2003 Jun;14(6):609-15. doi: 10.1046/j.1540-8167.2003.02577.x.

    PMID: 12875422BACKGROUND

  • Sohara H, Satake S, Tanaka K, et al. Modification of electrophysiological properties of pulmonary veins and adjacent left atrial tissue by radiofrequency thermal balloon circumferential ablation around the pulmonary vein ostia: correlation with non-recurrence of atrial fibrillation. Journal of Arrhythmia 21(3):384-397, 2005.

    BACKGROUND

  • Sohara H, Takeda H, Ueno H, Oda T, Satake S. Feasibility of the radiofrequency hot balloon catheter for isolation of the posterior left atrium and pulmonary veins for the treatment of atrial fibrillation. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):225-32. doi: 10.1161/CIRCEP.108.817205. Epub 2009 Apr 2.

    PMID: 19808472BACKGROUND

  • Sohara H, Satake S, Takeda H, et al. Radiofrequency hot balloon catheter ablation for the treatment of atrial fibrillation: a 3-center study in Japan. Journal of Arrhythmia 29:20-27, 2013

    BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Haines, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2013

First Posted

November 28, 2013

Study Start

November 22, 2013

Primary Completion

September 15, 2015

Study Completion

June 1, 2016

Last Updated

September 6, 2019

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)