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

Paroxysmal Atrial Fibrillation Clinical Trial

— FROZEN-AF  

Official title:

Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133168
• Other study ID #: PY004
• Status: Completed
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: August 17, 2023

Study information

• Verified date: December 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: August 17, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	UZ Brussels	Brussels
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Institut de Cardiologie de Montreal	Montreal
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Quebec
Canada	Vancouver General Hospital	Vancouver
France	CHU Grenoble - Hopital Michallon	Grenoble
Germany	Herz-und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Sha Tin
Italy	Maria Cecilia Hospital SPA	Cotignola
Netherlands	Erasmus MC- University Medical Center Rotterdam	Rotterdam
Taiwan	Taipei Veterans General Hospital	Taipei	Beitou District
Taiwan	National Taiwan University Hospital	Taipei City	Zhongzheng Dist
United States	Emory University Hospital	Atlanta	Georgia
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	Southcoast Physicians Group	Fall River	Massachusetts
United States	Stern Cardiovascular Foundation, Inc.	Germantown	Tennessee
United States	Aurora Health Care	Grafton	Wisconsin
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Arrhythmia Research Group	Jonesboro	Arkansas
United States	St. Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Kettering Medical Center	Kettering	Ohio
United States	Cedars - Sinai Medical Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	Banner University Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Chippenham & Johnston-Willis Hospital	Richmond	Virginia
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	Mercy General Hospital	Sacramento	California
United States	Northwell Health	Staten Island	New York
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	AdventHealth Tampa	Tampa	Florida
United States	St. Joseph's Hospital	Tampa	Florida
United States	Torrance Memorial Medical Center	Torrance	California
United States	Pima Heart and Vascular	Tucson	Arizona
United States	Christus Trinity Mother Frances Health System	Tyler	Texas
United States	PeaceHealth Southwest Medical	Vancouver	Washington
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Freedom From Recurrence	The following analysis looks at the recurrence free rate of individual atrial arrhythmia types as documented on a rhythm monitoring device post- blanking period.	12 Months
Primary	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
Primary	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
Primary	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
Primary	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	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	The achievement of electrical isolation of all PVs by using the POLARx Cardiac Cryoablation System. Electrical isolation of a PV is demonstrated by entrance and exit block.	1 day
Secondary	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	All Serious Adverse Events; All Study Procedure-Related Adverse Events; All Study Device-Related Adverse Events; All Study Device Deficiencies; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in Investigator's Brochure or DFU	12 months
Secondary	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	The following events will be counted through 7 days post index procedure or hospital discharge, whichever is later: Death, Myocardial infarction, Major Vagal Nerve Injury/Gastroparesis, Transient ischemic attack, Stroke/Cerebrovascular accident, Thromboembolism, Pneumothorax, Major vascular access complications, Pulmonary edema/heart failure, AV block. The following event will be counted through 30 days post index procedure: Cardiac tamponade/perforation. The following events will be counted through 12 months post index procedure: Atrial esophageal fistula, Severe pulmonary vein stenosis (=70% reduction in the diameter of the PV or PV branch from baseline), Persistent phrenic nerve palsy.	12 Months
Secondary	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	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 Cryoablation System 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