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

NCT04133168 | Completed Results DMC FDA Device

• 1 other identifier: PY004
• Study Type: interventional
• Target: 458
• Locations: 9 countries
• Sites: 44

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).

Conditions

Paroxysmal Atrial Fibrillation

Keywords

cryoablation

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Freedom From Primary Safety Events at 12 Months Post-procedure (Acute and Chronic Events) Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

  This measure reports the observed safety event-free rate at 12 Months follow up for all Non Roll-In treatment and intent subjects. The safety events are a composite of procedure-related and device-related adverse events. 7 days (Death, Myocardial infarction, Transient ischemic attack, Stroke/ Cerebrovascular accident, Vascular access complications, Mitral or tricuspid valvular damage, Thromboembolism/ Air embolism leading to a life-threatening event such as a ventricular arrhythmia, stroke, pulmonary embolism, or myocardial infarction and, thromboembolic events that result in permanent injury, require intervention for treatment or prolongs or require hospitalization for more than 48 hours, Gastroparesis/injury to vagus nerve, Pneumothorax, Pulmonary edema/heart failure AV block); 30 days (Cardiac tamponade/perforation); 12 months: (Atrial esophageal fistula, Severe Pulmonary vein stenosis, Persistent phrenic nerve palsy .

  12 Months

• Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

  Freedom from the composite of: Failure to achieve acute procedural success in the index procedure or repeat procedure during the blanking period; Use of amiodarone post index procedure; Surgical treatment for AF/AFL/AT post index procedure; Use of non-study ablation catheter for AF targets in the index procedure or repeat procedure during the blanking period; More than one repeat procedure with the POLARx catheter during the blanking period (90 days post index procedure); Documented AF, or new onset of AF or AT event 91-365 days post index procedure; Any of the following for AF, or new onset of AF or AT 91-365 days post index procedure: Repeat procedure - Electrical and/or pharmacological cardioversion for AF/AFL/AT - Prescribed AAD consisting of any Class I/III, including Amiodarone, and any Class II/IV medications taken for control of AF, AT, AFL recurrence

  12 Months

• Percentage of Participants With Freedom From Primary Safety Events at 3 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models

  Composite of procedure-related and device-related adverse events. 7 days post index procedure or hospital discharge, whichever is later, unless denoted as events counting through 3 months post index procedure (Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Cardiac tamponade/perforation, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block, Atrial esophageal fistula, severe pulmonary vein stenosis (≥70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy)

  3 months

• Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Fit Cryoablation Balloon Catheter Models

  The primary effectiveness endpoint is the rate of acute procedural success where acute procedural success is defined as the achievement of electrical isolation of all PVs by using the Cardiac Cryoablation System with the POLARx FIT cryoablation balloon catheter models (with treatment applied at 28 mm or 31 mm balloon size per physician discretion). Electrical isolation of a PV is demonstrated by entrance and exit block.

  1 day

Secondary Outcomes (4)

• Percentage of Participants With Acute Procedural Success Defined as the Achievement of Electrical Isolation of All PVs by Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter

  1 day

• Number of Participants With Freedom From Reportable Adverse Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx Cryoablation Balloon Catheter Models

  12 months

• Percentage of Participants With Freedom From Safety Events at 12 Months Post Procedure Using the Boston Scientific Cardiac Cryoablation System Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models

  12 Months

• Percentage of Participants With Freedom From Treatment Failure at 12 Months Post-procedure Using the Boston Scientific Cardiac Cryoablation System With POLARx FIT Cryoablation Balloon Catheter Models

  12 Months

Other Outcomes (1)

• Percentage of Participants With Freedom From Recurrence

  12 Months

Study Arms (1)

Cryoablation

EXPERIMENTAL

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

Device: Boston Scientific Cardiac Cryoablation System

Interventions

Boston Scientific Cardiac Cryoablation System 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

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Left ventricular ejection fraction (LVEF) \< 40% based on the most recent transthoracic echocardiogram (TTE) (≤180 days prior to enrollment);
• 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);
• An implanted pacemaker, ICD, CRT device or an arrhythmia loop recorder;
• Previous cardiac surgery: i.e. ventriculotomy or atriotomy (excluding atriotomy for CABG);
• Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve, including mitral valve clips;
• Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occlude;
• Presence of a left atrial appendage occlusion device;
• Presence of any pulmonary vein stents;
• Coronary artery bypass graft (CABG), PTCA/ PCI/ coronary stent procedures within 90 days prior to enrollment;
• Unstable angina or ongoing myocardial ischemia;

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (44)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Pima Heart and Vascular

Tucson, Arizona, 85712, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Cedars - Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

St. Joseph's Hospital

Tampa, Florida, 33614, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450-2736, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Northwell Health

Staten Island, New York, 10305, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Stern Cardiovascular Foundation, Inc.

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Christus Trinity Mother Frances Health System

Tyler, Texas, 75702, United States

Location

Chippenham & Johnston-Willis Hospital

Richmond, Virginia, 23225, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98664, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Aurora Health Care

Grafton, Wisconsin, 53024, United States

Location

UZ Brussels

Brussels, Belgium

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Québec, G1V 4G5, Canada

Location

Vancouver General Hospital

Vancouver, Canada

Location

CHU Grenoble - Hopital Michallon

Grenoble, 38043, France

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Lübeck, D-23538, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

Maria Cecilia Hospital SPA

Cotignola, Italy

Location

Erasmus MC- University Medical Center Rotterdam

Rotterdam, 3015 CE, Netherlands

Location

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 10002, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38448797 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Roelke, Clinical Trial Manager
• Organization: Boston Scientific

Stephanie.Roelke@bsci.com

651-582-4000

Study Officials

• Kenneth Ellenbogen, MD

  VCU Pauley Heart Center, Richmond, Virginia, USA

  STUDY CHAIR

• Arash Aryana, MD, PhD

  Mercy General Hospital,Sacramento, CA , USA

  PRINCIPAL INVESTIGATOR

• Nassir Marrouche, MD

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

  PRINCIPAL INVESTIGATOR

• Ante Anić, MD

  University Hospital, Split, Croatia

  PRINCIPAL INVESTIGATOR

• Suneet Mittal, MD,FACC,FHRS

  Snyder AF Center, New York, NY, USA

  PRINCIPAL INVESTIGATOR

• Niraj Varma, MD,PhD,FRCP

  Cleveland Clinic, Cleveland OH, USA

  PRINCIPAL INVESTIGATOR

• Wilber W Su, MD,FACC,FHRS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: open label, prospective, single arm study

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 21, 2019
• Study Start: June 24, 2020
• Primary Completion: November 10, 2022
• Study Completion: August 17, 2023
• Last Updated: April 3, 2025
• Results First Posted: December 7, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); CA (4); US (30); FR (1); BE (1); IT (1); NL (1); DE (2); TW (2)