Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)

Description

This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.

Study Start Date

June, 01 2016

Estimated Completion Date

March 2019

Interventions

  • Device: THERMOCOOL SMARTTOUCH® SF catheter

Study ID

Biosense Webster, Inc. -- STSF-159

Status

Recruiting

Trial ID

NCT02817776

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

367

Sponsor

Biosense Webster, Inc.

Inclusion Criteria

    Candidates for this study must meet ALL of the following criteria: 1. Documented symptomatic persistent AF, which is defined as continuous AF sustains beyond 7 days and less than 1 year and is documented by the following:. 1. Physician's note indicating continuous AF ? 7 days but no more than 1 year AND 2. Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart OR 3. 24-hour Holter within 90 days of the ablation procedure showing continuous AF 2. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD. 3. Age 18 years or older. 4. Signed Patient Informed Consent Form (ICF). 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria

    Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply: 1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) 2. Previous surgical or catheter ablation for atrial fibrillation 3. Any cardiac surgery within the past 2 months (60 days) (includes PCI) 4. CABG surgery within the past 6 months (180 days) 5. Valvular cardiac surgical/percutaneous procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) 6. Any carotid stenting or endarterectomy 7. Documented LA thrombus on imaging 8. LA size > 50 mm (parasternal long axis view) 9. LVEF < 40% 10. Contraindication to anticoagulation (heparin or warfarin) 11. History of blood clotting or bleeding abnormalities 12. MI within the past 2 months (60 days) 13. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 14. Rheumatic Heart Disease 15. Uncontrolled heart failure or NYHA function class III or IV 16. Severe mitral regurgitation (Regurgitant volume ? 60 mL/beat, Regurgitant fraction ? 50%, and/or Effective regurgitant orifice area ? 0.40cm2) 17. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 18. Unstable angina 19. Acute illness or active systemic infection or sepsis 20. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. 21. Diagnosed atrial myxoma. 22. Presence of implanted ICD/CRT-D. 23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms. 24. Gastroesophageal Reflux Disease (GERD active requiring significant intervention not including OTC medication) 25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 27. Enrollment in an investigational study evaluating another device, biologic, or drug. 28. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter. 29. Presence of any other condition that precludes appropriate vascular access. 30. Life expectancy less than 12 months

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (118)

Study Location Distance Name Phone Email
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Deborah Elizabeth Manuelian None dmanuelian@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Deborah Elizabeth Manuelian None dmanuelian@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Deborah Elizabeth Manuelian None dmanuelian@bwh.harvard.edu
Brigham and Womens Hospital - Boston, Massachusetts 2.6 miles Deborah Elizabeth Manuelian None dmanuelian@bwh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Belma Halilovic None bhalilovic@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Belma Halilovic None bhalilovic@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Belma Halilovic None bhalilovic@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Belma Halilovic None bhalilovic@mgh.harvard.edu
St Francis Hospital - Roslyn, New York 172.1 miles Elizabeth Haag None Elizabeth.Haag@chsli.org
St Francis Hospital - Roslyn, New York 172.1 miles Elizabeth Haag None Elizabeth.Haag@chsli.org
St Francis Hospital - Roslyn, New York 172.1 miles Elizabeth Haag None Elizabeth.Haag@chsli.org
St Francis Hospital - Roslyn, New York 172.1 miles Elizabeth Haag None Elizabeth.Haag@chsli.org
Montefiore Hospital - The Bronx, New York 176.6 miles Dalvert Polanco None DAPOLANC@montefiore.org
Montefiore Hospital - The Bronx, New York 176.6 miles Dalvert Polanco None DAPOLANC@montefiore.org
Montefiore Hospital - The Bronx, New York 176.6 miles Dalvert Polanco None DAPOLANC@montefiore.org
Montefiore Hospital - The Bronx, New York 176.6 miles Dalvert Polanco None DAPOLANC@montefiore.org
Mount Sinai School of Medicine - New York, New York 183.2 miles Betsy Ellsworth None betsy.ellsworth@mountsinai.org
Mount Sinai School of Medicine - New York, New York 183.2 miles Betsy Ellsworth None betsy.ellsworth@mountsinai.org
Mount Sinai School of Medicine - New York, New York 183.2 miles Betsy Ellsworth None betsy.ellsworth@mountsinai.org
Mount Sinai School of Medicine - New York, New York 183.2 miles Betsy Ellsworth None betsy.ellsworth@mountsinai.org
New York Presbyterian Hospital Weill Cornell Medical Center - New York, New York 187.1 miles Grace Lee None grl2008@med.cornell.edu
New York Presbyterian Hospital Weill Cornell Medical Center - New York, New York 187.1 miles Grace Lee None grl2008@med.cornell.edu
New York Presbyterian Hospital Weill Cornell Medical Center - New York, New York 187.1 miles Grace Lee None grl2008@med.cornell.edu
New York Presbyterian Hospital Weill Cornell Medical Center - New York, New York 187.1 miles Grace Lee None grl2008@med.cornell.edu
New York University - New York, New York 187.6 miles Jessica Holzman None Jessica.Holzman@nyumc.org
New York University - New York, New York 187.6 miles Jessica Holzman None Jessica.Holzman@nyumc.org
New York University - New York, New York 187.6 miles Jessica Holzman None Jessica.Holzman@nyumc.org
New York University - New York, New York 187.6 miles Jessica Holzman None Jessica.Holzman@nyumc.org
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles Linda Murphy None Linda.Murphy@hackensackmeridian.org
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles Linda Murphy None Linda.Murphy@hackensackmeridian.org
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles Linda Murphy None Linda.Murphy@hackensackmeridian.org
Jersey Shore University Medical Center - Neptune City, New Jersey 214.3 miles Linda Murphy None Linda.Murphy@hackensackmeridian.org
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Mary Gnap None Mary.Gnap@uphs.upenn.edu
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Mary Gnap None Mary.Gnap@uphs.upenn.edu
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Mary Gnap None Mary.Gnap@uphs.upenn.edu
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Mary Gnap None Mary.Gnap@uphs.upenn.edu
Johns Hopkins University - Baltimore, Maryland 356.0 miles Michele Martucci None mmill148@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.0 miles Michele Martucci None mmill148@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.0 miles Michele Martucci None mmill148@jhmi.edu
Johns Hopkins University - Baltimore, Maryland 356.0 miles Michele Martucci None mmill148@jhmi.edu
Sentara Heart Hospital - Norfolk, Virginia 471.1 miles Brittany McMichael None BYMCMICH@sentara.com
Sentara Heart Hospital - Norfolk, Virginia 471.1 miles Brittany McMichael None BYMCMICH@sentara.com
Sentara Heart Hospital - Norfolk, Virginia 471.1 miles Brittany McMichael None BYMCMICH@sentara.com
Sentara Heart Hospital - Norfolk, Virginia 471.1 miles Brittany McMichael None BYMCMICH@sentara.com
Virginia Commonwealth University - Richmond, Virginia 474.2 miles Melissa Hockman None Melissa.Hockman@vcuhealth.org
Virginia Commonwealth University - Richmond, Virginia 474.2 miles Melissa Hockman None Melissa.Hockman@vcuhealth.org
Virginia Commonwealth University - Richmond, Virginia 474.2 miles Melissa Hockman None Melissa.Hockman@vcuhealth.org
Virginia Commonwealth University - Richmond, Virginia 474.2 miles Melissa Hockman None Melissa.Hockman@vcuhealth.org
Cleveland Clinic Foundation - Cleveland, Ohio 549.6 miles Melanie Panko None pankom@ccf.org
Cleveland Clinic Foundation - Cleveland, Ohio 549.6 miles Melanie Panko None pankom@ccf.org
Cleveland Clinic Foundation - Cleveland, Ohio 549.6 miles Melanie Panko None pankom@ccf.org
Cleveland Clinic Foundation - Cleveland, Ohio 549.6 miles Melanie Panko None pankom@ccf.org
Duke University Medical Center - Durham, North Carolina 606.5 miles Susan Gerstl None susan.gerstl@duke.edu
Duke University Medical Center - Durham, North Carolina 606.5 miles Susan Gerstl None susan.gerstl@duke.edu
Duke University Medical Center - Durham, North Carolina 606.5 miles Susan Gerstl None susan.gerstl@duke.edu
Duke University Medical Center - Durham, North Carolina 606.5 miles Susan Gerstl None susan.gerstl@duke.edu
Emory Saint Josephs Hospital - Atlanta, Georgia 929.9 miles Cindy Barnes None Cynthia.barnes@emory.edu
Emory Saint Josephs Hospital - Atlanta, Georgia 929.9 miles Cindy Barnes None Cynthia.barnes@emory.edu
Emory Saint Josephs Hospital - Atlanta, Georgia 929.9 miles Cindy Barnes None Cynthia.barnes@emory.edu
Emory Saint Josephs Hospital - Atlanta, Georgia 929.9 miles Cindy Barnes None Cynthia.barnes@emory.edu
St Vincents Medical Center - Jacksonville, Florida 1,020.0 miles Lisa Joseph None Lisa.Joseph@ascension.org
St Vincents Medical Center - Jacksonville, Florida 1,020.0 miles Lisa Joseph None Lisa.Joseph@ascension.org
St Vincents Medical Center - Jacksonville, Florida 1,020.0 miles Lisa Joseph None Lisa.Joseph@ascension.org
St Vincents Medical Center - Jacksonville, Florida 1,020.0 miles Lisa Joseph None Lisa.Joseph@ascension.org
University of Iowa - Iowa City, Iowa 1,050.4 miles Traci Shirkey None traci-shirkey@uiowa.edu
University of Iowa - Iowa City, Iowa 1,050.4 miles Traci Shirkey None traci-shirkey@uiowa.edu
University of Iowa - Iowa City, Iowa 1,050.4 miles Traci Shirkey None traci-shirkey@uiowa.edu
University of Iowa - Iowa City, Iowa 1,050.4 miles Traci Shirkey None traci-shirkey@uiowa.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles Michele Blue None mblue@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles Michele Blue None mblue@uabmc.edu
University of Alabama at Birmingham - Birmingham, Alabama 1,052.1 miles Michele Blue None mblue@uabmc.edu
Affinity Cardiovascular Specialists Alabama Cardiovascular Group - Birmingham, Alabama 1,052.4 miles Susan Thorington None sthorington@alcardio.com
Affinity Cardiovascular Specialists Alabama Cardiovascular Group - Birmingham, Alabama 1,052.4 miles Susan Thorington None sthorington@alcardio.com
Affinity Cardiovascular Specialists Alabama Cardiovascular Group - Birmingham, Alabama 1,052.4 miles Susan Thorington None sthorington@alcardio.com
Affinity Cardiovascular Specialists Alabama Cardiovascular Group - Birmingham, Alabama 1,052.4 miles Susan Thorington None sthorington@alcardio.com
Mayo Clinic Foundation - Rochester, Minnesota 1,083.2 miles Kristi Monahan None Monahan.Kristi@mayo.edu
Mayo Clinic Foundation - Rochester, Minnesota 1,083.2 miles Kristi Monahan None Monahan.Kristi@mayo.edu
Mayo Clinic Foundation - Rochester, Minnesota 1,083.2 miles Kristi Monahan None Monahan.Kristi@mayo.edu
Mayo Clinic Foundation - Rochester, Minnesota 1,083.2 miles Kristi Monahan None Monahan.Kristi@mayo.edu
Florida Hospital - Orlando, Florida 1,115.8 miles Leann Goodwin None Leann.Goodwin@FLHOSP.ORG
Florida Hospital - Orlando, Florida 1,115.8 miles Leann Goodwin None Leann.Goodwin@FLHOSP.ORG
Florida Hospital - Orlando, Florida 1,115.8 miles Leann Goodwin None Leann.Goodwin@FLHOSP.ORG
Florida Hospital - Orlando, Florida 1,115.8 miles Leann Goodwin None Leann.Goodwin@FLHOSP.ORG
Abbott Northwestern Hospital - Minneapolis, Minnesota 1,120.8 miles Jacob Cohen None Jacob.Cohen@allina.com
Abbott Northwestern Hospital - Minneapolis, Minnesota 1,120.8 miles Jacob Cohen None Jacob.Cohen@allina.com
Abbott Northwestern Hospital - Minneapolis, Minnesota 1,120.8 miles Jacob Cohen None Jacob.Cohen@allina.com
Abbott Northwestern Hospital - Minneapolis, Minnesota 1,120.8 miles Jacob Cohen None Jacob.Cohen@allina.com
Baylor Research Institute - Plano, Texas 1,549.8 miles Penni Dolton None Penni.Dolton@BSWHealth.org
Baylor Research Institute - Plano, Texas 1,549.8 miles Penni Dolton None Penni.Dolton@BSWHealth.org
Baylor Research Institute - Plano, Texas 1,549.8 miles Penni Dolton None Penni.Dolton@BSWHealth.org
Baylor Research Institute - Plano, Texas 1,549.8 miles Penni Dolton None Penni.Dolton@BSWHealth.org
Texas Health Heart Vascular Hospital - Arlington, Texas 1,568.4 miles Felicity Vaughan None feefeevaughan88@gmail.com
Texas Health Heart Vascular Hospital - Arlington, Texas 1,568.4 miles Felicity Vaughan None feefeevaughan88@gmail.com
Texas Health Heart Vascular Hospital - Arlington, Texas 1,568.4 miles Felicity Vaughan None feefeevaughan88@gmail.com
Texas Health Heart Vascular Hospital - Arlington, Texas 1,568.4 miles Felicity Vaughan None feefeevaughan88@gmail.com
Texas Cardiac Arrhythmia Research - Austin, Texas 1,695.0 miles Deb Cardinal None dscardinal@austinheartbeat.com
Texas Cardiac Arrhythmia Research - Austin, Texas 1,695.0 miles Deb Cardinal None dscardinal@austinheartbeat.com
Texas Cardiac Arrhythmia Research - Austin, Texas 1,695.0 miles Deb Cardinal None dscardinal@austinheartbeat.com
Texas Cardiac Arrhythmia Research - Austin, Texas 1,695.0 miles Deb Cardinal None dscardinal@austinheartbeat.com
Phoenix Cardiovascular Research Group - Phoenix, Arizona 2,298.4 miles Aneta Scafaru None ascafaru@iri-az.com
Phoenix Cardiovascular Research Group - Phoenix, Arizona 2,298.4 miles Aneta Scafaru None ascafaru@iri-az.com
Phoenix Cardiovascular Research Group - Phoenix, Arizona 2,298.4 miles Aneta Scafaru None ascafaru@iri-az.com
JFK Medical Center - Atlantis, Florida 2,478.7 miles Mila Moreiras None mila.moreiras@scresearch.net
JFK Medical Center - Atlantis, Florida 2,478.7 miles Mila Moreiras None mila.moreiras@scresearch.net
JFK Medical Center - Atlantis, Florida 2,478.7 miles Mila Moreiras None mila.moreiras@scresearch.net
JFK Medical Center - Atlantis, Florida 2,478.7 miles Mila Moreiras None mila.moreiras@scresearch.net
San Diego Cardiac Center - San Diego, California 2,579.1 miles Donna Small None DSmall@sdcardiac.com
San Diego Cardiac Center - San Diego, California 2,579.1 miles Donna Small None DSmall@sdcardiac.com
San Diego Cardiac Center - San Diego, California 2,579.1 miles Donna Small None DSmall@sdcardiac.com
San Diego Cardiac Center - San Diego, California 2,579.1 miles Donna Small None DSmall@sdcardiac.com
Good Samaritan Hospital - Los Angeles, California 2,596.3 miles Young Park None ypark@GoodSam.Org
Good Samaritan Hospital - Los Angeles, California 2,596.3 miles Young Park None ypark@GoodSam.Org
Good Samaritan Hospital - Los Angeles, California 2,596.3 miles Young Park None ypark@GoodSam.Org
Good Samaritan Hospital - Los Angeles, California 2,596.3 miles Young Park None ypark@GoodSam.Org
Stanford University School of Medicine - Palo Alto, California 2,694.5 miles Gerri ORiordan None GORiordan@stanfordhealthcare.org
Stanford University School of Medicine - Palo Alto, California 2,694.5 miles Gerri ORiordan None GORiordan@stanfordhealthcare.org
Stanford University School of Medicine - Palo Alto, California 2,694.5 miles Gerri ORiordan None GORiordan@stanfordhealthcare.org
Stanford University School of Medicine - Palo Alto, California 2,694.5 miles Gerri ORiordan None GORiordan@stanfordhealthcare.org

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