Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

NCT ID: NCT04133168

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2023-08-17

Brief Summary

To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

Detailed Description

Multi-center, open label, prospective, single arm study to document the safety and performance of Boston Scientific's Cryoablation System. The Cryoablation System is intended for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for twelve (12) months after the index procedure.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoablation

Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System

Group Type: EXPERIMENTAL

Boston Scientific Cardiac Cryoablation System

Intervention Type: DEVICE

The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following:

• POLARx™ or POLARx™ FIT Cryoablation Catheter
• POLARMAP™ Catheter
• POLARSHEATH™
• SMARTFREEZE™ Console
• Diaphragm Movement Sensor (DMS)
• Related Accessories

Interventions

Boston Scientific Cardiac Cryoablation System

The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following:

• POLARx™ or POLARx™ FIT Cryoablation Catheter
• POLARMAP™ Catheter
• POLARSHEATH™
• SMARTFREEZE™ Console
• Diaphragm Movement Sensor (DMS)
• Related Accessories

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• History of recurrent symptomatic paroxysmal atrial fibrillation (PAF), defined as atrial fibrillation that terminates spontaneously or with intervention (either procedure or drug therapy) within seven days of onset. Minimum documentation includes the following:

• a physician's note indicating recurrent self-terminating atrial fibrillation (AF) which includes at least two symptomatic AF episodes within six months prior to enrollment, and one electrocardiographically documented AF episode within 12 months prior to enrollment.
• No amiodarone use within 90 days prior to enrollment;
• Subjects who are indicated for an ablation procedure for paroxysmal atrial fibrillation (PAF) according to 2017 HRS expert consensus statement on catheter and surgical ablation of atrial fibrillation;
• Subjects refractory or intolerant to at least one class I or III antiarrhythmic medication;
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria

• Any known contraindication to an AF ablation or anticoagulation;
• Continuous AF lasting longer than seven (7) days from onset;
• History of previous left atrial ablation or surgical treatment for AF/ AFL/ AT;
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
• Structural heart disease or implanted devices as described below:

1. Left ventricular ejection fraction (LVEF) < 40% based on the most recent transthoracic echocardiogram (TTE) (≤180 days prior to enrollment);

2. Left atrial diameter > 55 mm OR left atrial volume > 50 ml/m2 ml indexed based on the most recent TTE (≤ 180 days prior to enrollment);

3. An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder;

4. Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding atriotomy for CABG);

5. Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips;

6. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occlude;

7. Presence of a left atrial appendage occlusion device;

8. Presence of any pulmonary vein stents;

9. Coronary artery bypass graft (CABG), PTCA/ PCI/ coronary stent procedures within 90 days prior to enrollment;

10. Unstable angina or ongoing myocardial ischemia;

11. myocardial infarction within 90 days prior to enrollment;

12. Moderate or severe mitral insufficiency assessed on the most recent TTE (≤180 days prior to enrollment, e.g. pulmonary artery pressure >30 mmHg);

13. Evidence of left atrial thrombus;

• Any previous history of cryoglobulinemia;
• Stage 3B or higher renal disease (estimated glomerular filtration rate, eGFR <45 mL/min);
• History of blood clotting or bleeding disease;
• Any prior history of documented cerebral infarct, TIA or systemic embolism [excluding a post-operative deep vein thrombosis (DVT)] ≤180 days prior to enrollment;
• Active systemic infection;
• Pregnant, lactating (current or anticipated during study follow up), or women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility;
• Subjects who in the judgment of the investigator have a life expectancy of less than two years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Ellenbogen, MD

Role: STUDY_CHAIR

VCU Pauley Heart Center, Richmond, Virginia, USA

Arash Aryana, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mercy General Hospital,Sacramento, CA , USA

Nassir Marrouche, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah School of Medicine. Slat Lake City, UT, USA

Ante Anić, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Split, Croatia

Suneet Mittal, MD,FACC,FHRS

Role: PRINCIPAL_INVESTIGATOR

Snyder AF Center, New York, NY, USA

Niraj Varma, MD,PhD,FRCP

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Cleveland OH, USA

Wilber W Su, MD,FACC,FHRS

Role: PRINCIPAL_INVESTIGATOR

Banner- University Medical Group- Heart Center, Phoenix, AZ, USA

Locations

Banner University Medical Center

Phoenix, Arizona, United States

Pima Heart and Vascular

Tucson, Arizona, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Cedars - Sinai Medical Center

Los Angeles, California, United States

Mercy General Hospital

Sacramento, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

AdventHealth Tampa

Tampa, Florida, United States

St. Joseph's Hospital

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Southcoast Physicians Group

Fall River, Massachusetts, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Valley Hospital

Ridgewood, New Jersey, United States

Mount Sinai Medical Center

New York, New York, United States

Northwell Health

Staten Island, New York, United States

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Heart & Vascular Hospital

Dallas, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

Chippenham & Johnston-Willis Hospital

Richmond, Virginia, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

PeaceHealth Southwest Medical

Vancouver, Washington, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

Aurora Health Care

Grafton, Wisconsin, United States

UZ Brussels

Brussels, , Belgium

Hamilton General Hospital

Hamilton, Ontario, Canada

Institut de Cardiologie de Montreal

Montreal, , Canada

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, , Canada

Vancouver General Hospital

Vancouver, , Canada

CHU Grenoble - Hopital Michallon

Grenoble, , France

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, , Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Queen Mary Hospital

Hong Kong, , Hong Kong

Prince of Wales Hospital

Shatin, , Hong Kong

Maria Cecilia Hospital SPA

Cotignola, , Italy

Erasmus MC- University Medical Center Rotterdam

Rotterdam, , Netherlands

Taipei Veterans General Hospital

Taipei, Beitou District, Taiwan

National Taiwan University Hospital

Taipei, Zhongzheng Dist, Taiwan

Countries

United States; Belgium; Canada; France; Germany; Hong Kong; Italy; Netherlands; Taiwan

References

Ellenbogen KA, Mittal S, Varma N, Aryana A, Marrouche N, Anic A, Nair D, Champagne J, Iacopino S, de Asmundis C, Weiner S, Makati K, Raybuck JD, Richards E, Su W. One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial. J Cardiovasc Electrophysiol. 2024 Apr;35(4):832-842. doi: 10.1111/jce.16220. Epub 2024 Mar 6.

Reference Type: RESULT

PMID: 38448797 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PY004

Identifier Type: -

Identifier Source: org_study_id