NCT01716663

Brief Summary

This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

26 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

Study Start

First participant enrolled

October 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 1, 2014

Completed
Last Updated

December 1, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

October 19, 2012

Results QC Date

November 24, 2014

Last Update Submit

November 24, 2014

Conditions

Atrial FibrillationParoxysmal AF

Keywords

Symptomatic paroxysmalAtrial fibrillationObservationalAcute procedural outcomesAblation

Outcome Measures

Primary Outcomes (1)

  • Total Fluoroscopy Time

    The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.

    Day 0

Secondary Outcomes (4)

  • Total Procedure Time

    Day 0

  • Acute Procedural Success

    Day 0

  • Mean Number of Radiofrequency (RF) Applications

    Day 0

  • Total Radiofrequency (RF) Time

    Day 0

Study Arms (1)

Experimental: Catheter Ablation

These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.

Device: Catheter Ablation

Interventions

Catheter AblationDEVICE

NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)

Also known as: CARTO® 3 System and Real Time Intracardiac Ultrasound
Experimental: Catheter Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF

You may qualify if:

  • Drug refractory, recurrent symptomatic paroxysmal AF
  • Age 18 years or older
  • Patients able and willing to provide written informed consent to participate in the study and comply with study requirements

You may not qualify if:

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous ablation for atrial fibrillation
  • AF episodes that last longer than 30 days
  • Uncontrolled heart failure, or NYHA Class III or IV heart failure
  • Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
  • Contraindication to anticoagulation
  • Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
  • Awaiting cardiac transplantation
  • Heart disease for which corrective surgery is anticipated within 6 months
  • Enrollment in other investigational drug or device study
  • Subjects unwilling to comply with protocol or follow-up requirements
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

AZ Heart Rhythm Research Center

Phoenix, Arizona, 85013, United States

Location

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, 85260, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.

Jacksonville, Florida, 33204, United States

Location

Osceola Regional Medical Center

Kissimmee, Florida, 34741, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Pepin Heart Hospital

Tampa, Florida, 33613, United States

Location

Northeast Georgia Heart Center, PC

Gainsville, Georgia, 30501, United States

Location

Provena St. Joseph Medical Center

Joliet, Illinois, 60435, United States

Location

Washington Adventist Hospital CCVR

Takoma Park, Maryland, 20912, United States

Location

Michigan CardioVascular Institute

Saginaw, Michigan, 48601, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

St. Mary Medical Center

Newtown, Pennsylvania, 18940, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Geisinger Heart Institute

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Northeast Baptist Hospital

San Antonio, Texas, 78217, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Ellen Harris, Project Manager, Clinical Operations
Organization
Biosense Webster
eharris8@its.jnj.com
909-839-7376

Study Officials

  • Usman Siddiqui, MD

    Osceola Regional Medical Center

    PRINCIPAL INVESTIGATOR

  • Mathew Hutchinson, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Andy Tran, MD

    Scottsdale Healthcare Research

    PRINCIPAL INVESTIGATOR

  • Saumil Oza, MD

    East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.

    PRINCIPAL INVESTIGATOR

  • Robert Fishel, MD

    JFK Medical Center

    PRINCIPAL INVESTIGATOR

  • Vijendra Swarup, MD

    AZ Heart Rhythm Research Center

    PRINCIPAL INVESTIGATOR

  • Mohit Rastogi, MD

    Washington Adventist Hospital CCVR

    PRINCIPAL INVESTIGATOR

  • Brett Gidney, MD

    Santa Barbara Cottage Hospital

    PRINCIPAL INVESTIGATOR

  • John Scherschel, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

  • Dilip Mathew, MD

    Pepin Heart Hospital

    PRINCIPAL INVESTIGATOR

  • William Sauer, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Marcie Berger, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

  • Khawaja Baig, MD

    Kettering Medical Center

    PRINCIPAL INVESTIGATOR

  • Farhat Khairallah, MD

    Tallahassee Research Institute

    PRINCIPAL INVESTIGATOR

  • David Fitzgerald, MD

    Scott & White Memorial Hospital

    PRINCIPAL INVESTIGATOR

  • Gopi Dandamudi, MD

    Geisinger Heart Institute

    PRINCIPAL INVESTIGATOR

  • Ahmad Abdul-Karim, MD

    Provena St. Joseph Medical Center

    PRINCIPAL INVESTIGATOR

  • Douglas Esberg, MD

    Main Line Health

    PRINCIPAL INVESTIGATOR

  • Scott Burke, MD

    St. Mary's Medical Center

    PRINCIPAL INVESTIGATOR

  • Gregory Jones, MD

    Wellmont CVA Heart Institute

    PRINCIPAL INVESTIGATOR

  • Tapan Rami, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Salem Sayar, MD

    Northeast Georgia Heart Center, PC

    PRINCIPAL INVESTIGATOR

  • Gunjan Shukla, MD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

  • Philip Gentlesk, MD

    Sentara Norfolk General Hospital

    PRINCIPAL INVESTIGATOR

  • Asim Yunus, MD

    Michigan CardioVascular Institute

    PRINCIPAL INVESTIGATOR

  • Scott Reich, MD

    Northeast Baptist Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 30, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 1, 2014

Results First Posted

December 1, 2014

Record last verified: 2014-11

Locations

US(26)