Clinical trial NCT04133168: Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Official title: Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: cryoablation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label, prospective, single arm study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 12 Months
measure: 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
timeFrame: 12 Months
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 1 day
Secondary outcomes:
measure: 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
timeFrame: 1 day
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 Months
measure: 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
timeFrame: 12 Months
Other outcomes:
measure: Percentage of Participants With Freedom From Recurrence
timeFrame: 12 Months
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Jonesboro
country: United States
facility: Arrhythmia Research Group
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Fall River
country: United States
facility: Southcoast Physicians Group
state: Massachusetts
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Staten Island
country: United States
facility: Northwell Health
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation, Inc.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Mother Frances Health System
state: Texas
city: Richmond
country: United States
facility: Chippenham & Johnston-Willis Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Grafton
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Brussels
country: Belgium
facility: UZ Brussels
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
city: Quebec
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital SPA
city: Rotterdam
country: Netherlands
facility: Erasmus MC- University Medical Center Rotterdam
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist
Study officials:
affiliation: VCU Pauley Heart Center, Richmond, Virginia, USA
name: Kenneth Ellenbogen, MD
role: STUDY_CHAIR
affiliation: Mercy General Hospital,Sacramento, CA , USA
name: Arash Aryana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah School of Medicine. Slat Lake City, UT, USA
name: Nassir Marrouche, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Split, Croatia
name: Ante Anić, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Snyder AF Center, New York, NY, USA
name: Suneet Mittal, MD,FACC,FHRS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic, Cleveland OH, USA
name: Niraj Varma, MD,PhD,FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Banner- University Medical Group- Heart Center, Phoenix, AZ, USA
name: Wilber W Su, MD,FACC,FHRS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.