nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Phase 3

Terminated

Conditions: Atrial Fibrillation

Interventions: Device: NaviStar ThermoCool Catheters
Device: nMARQ Navigation Catheters

Registration Number: NCT01824394

Lead Sponsor: Biosense Webster, Inc.

Brief Summary: To demonstrate safety and effectiveness of nMARQ Catheter System \[nMARQ\] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 481

Inclusion Criteria

Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
Age 18 years or older.
Signed Patient Informed Consent Form (ICF).
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria

AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
Previous ablation for atrial fibrillation.
Patients on amiodarone at any time during the past 3 months prior to enrollment.
AF episodes lasting > 7 days.
Any cardiac surgery within the past 60 days (2 months).
Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
Documented left atrial thrombus on imaging.
History of a documented thromboembolic event within the past one (1) year.
Diagnosed atrial myxoma.
Presence of implanted cardioverter defibrillator (ICD).
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.
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
Acute illness or active systemic infection or sepsis.
Unstable angina.
Myocardial infarction within the previous 60 days (2 months).
Left ventricular ejection fraction <40%.
History of blood clotting or bleeding abnormalities.
Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
Life expectancy less than 365 days (12 months).
Enrollment in an investigational study evaluating another device or drug.
Uncontrolled heart failure or NYHA Class III or IV heart failure.
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
Presence of a condition that precludes vascular access.
Left atrial size >50 mm.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaviStar ThermoCool Catheters	NaviStar ThermoCool Catheters	THERMOCOOL® Navigational family of catheters
nMARQ Catheter	nMARQ Navigation Catheters	nMARQ Catheter System

Primary Outcome Measures

Name	Time	Method
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population	30 days post-procedure	The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Number of Participants With Early Onset Primary Adverse Events	30 days post-procedure	The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (48): University of Chicago
🇺🇸
Chicago, Illinois, United States
Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
University of Pennsylvania Health System
🇺🇸
Philadelphia, Pennsylvania, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
University of Kansas Hospital
🇺🇸
Kansas City, Kansas, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Centennial Heart
🇺🇸
Nashville, Tennessee, United States
Clinique Saint-Pierre Ottignies
🇧🇪
Ottignies, Belgium
Our Lady of Lourdes Medical Center
🇺🇸
Voorhees, New Jersey, United States
Hoag Memorial Hospital Presbyterian
🇺🇸
Newport Beach, California, United States
University of Alabama Hospital
🇺🇸
Birmingham, Alabama, United States
Arizona Heart Rhythm Center
🇺🇸
Phoenix, Arizona, United States
Good Samaritan Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
Stanford Hospital and Clinics
🇺🇸
Palo Alto, California, United States
Sequoia Hospital
🇺🇸
Redwood City, California, United States
Florida Hospital Memorial Medical Center
🇺🇸
New Smyrna Beach, Florida, United States
St. Vincent's Medical Center
🇺🇸
Jacksonville, Florida, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
New York University
🇺🇸
New York, New York, United States
Einstein Medical Center Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Mount Sinai School of Medicine, The
🇺🇸
New York, New York, United States
Texas Cardiac Arrhythmia Research - St. David's
🇺🇸
Austin, Texas, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
Ohio State University Medical Center, The
🇺🇸
Columbus, Ohio, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Virginia Commonwealth University Medical Center
🇺🇸
Richmond, Virginia, United States
Imelda Ziekenhuis
🇧🇪
Imeldalaan, Bonheiden, Belgium
Semmelweis University Heart and Vascular Center
🇭🇺
Budapest, Városmajor U, Hungary
Ospedale Generale Regionale "F. Miulli"
🇮🇹
Acquaviva Delle Fonti, Bari, Italy
Centro Cardiologico Monzino
🇮🇹
Milano, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ospedale San Giovanni Battista - Molinette
🇮🇹
Torino, Italy
Ospedale Cardinal Massaia
🇮🇹
Asti, Italy
Freeman Hospital
🇬🇧
Newcastle, United Kingdom
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Nemocnice Na Homolce
🇨🇿
Prague, Czechia
Glenfield Hospital
🇬🇧
Leicester, Leicestershire, United Kingdom
Florida Hospital
🇺🇸
Orlando, Florida, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
University of Michigan Health System
🇺🇸
Ann Arbor, Michigan, United States
Morristown Medical Center
🇺🇸
Morristown, New Jersey, United States