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FROZEN-AF: Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04133168
Collaborator
(none)
454
Enrollment
44
Locations
1
Arm
38.3
Anticipated Duration (Months)
10.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Boston Scientific Cardiac Cryoablation System
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
454 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
open label, prospective, single arm studyopen label, prospective, single arm study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Actual Study Start Date :
Jun 24, 2020
Anticipated Primary Completion Date :
Nov 3, 2022
Anticipated Study Completion Date :
Sep 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cryoablation

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

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

Outcome Measures

Primary Outcome Measures

  1. Rate of 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 [12 Months]

    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 .

  2. Freedom from Treatment Failure at 12 Months post-procedure using the Boston Scientific Cardiac Cryoablation system with POLARx cryoablation balloon catheter models [12 Months]

    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

  3. Rate of Primary Safety Events at 3 months post procedure using the Boston Scientific Cardiac Cryoablation system with POLARx FIT cryoablation balloon catheter models [3 months]

    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)

  4. Rate of 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 [1 day]

    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.

Secondary Outcome Measures

  1. Rate of 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]

    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.

  2. Rate of reportable Adverse Events at 12 months post procedure using the Boston Scientific Cardiac Cryoablation system with POLARx cryoablation balloon catheter models [12 months]

    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

  3. Rate of 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]

    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.

  4. 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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner University Medical Center Phoenix Arizona United States 85006
2 Pima Heart and Vascular Tucson Arizona United States 85712
3 Arrhythmia Research Group Jonesboro Arkansas United States 72401
4 Cedars - Sinai Medical Center Los Angeles California United States 90048
5 Mercy General Hospital Sacramento California United States 95819
6 Torrance Memorial Medical Center Torrance California United States 90505
7 Tallahassee Memorial Hospital Tallahassee Florida United States 32308
8 AdventHealth Tampa Tampa Florida United States 33613
9 St. Joseph's Hospital Tampa Florida United States 33614
10 Emory University Hospital Atlanta Georgia United States 30308
11 Rush University Medical Center Chicago Illinois United States 60612
12 Southcoast Physicians Group Fall River Massachusetts United States 02720
13 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
14 Valley Hospital Ridgewood New Jersey United States 07450-2736
15 Mount Sinai Medical Center New York New York United States 10029
16 Northwell Health Staten Island New York United States 10305
17 St. Joseph's Hospital Health Center Syracuse New York United States 13203
18 Cleveland Clinic Foundation Cleveland Ohio United States 44195
19 Kettering Medical Center Kettering Ohio United States 45429
20 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
21 York Hospital York Pennsylvania United States 17403
22 Stern Cardiovascular Foundation, Inc. Germantown Tennessee United States 38138
23 Vanderbilt University Medical Center Nashville Tennessee United States 37232
24 Baylor Heart & Vascular Hospital Dallas Texas United States 75226
25 Christus Trinity Mother Frances Health System Tyler Texas United States 75702
26 Chippenham & Johnston-Willis Hospital Richmond Virginia United States 23225
27 Virginia Commonwealth University Health System Richmond Virginia United States 23298
28 PeaceHealth Southwest Medical Vancouver Washington United States 98664
29 St. Mary's Medical Center Huntington West Virginia United States 25702
30 Aurora Health Care Grafton Wisconsin United States 53024
31 UZ Brussels Brussels Belgium
32 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
33 Institut de Cardiologie de Montreal Montreal Canada
34 Institut universitaire de Cardiologie et de Pneumologie de Quebec Quebec Canada G1V 4G5
35 Vancouver General Hospital Vancouver Canada
36 CHU Grenoble - Hopital Michallon Grenoble France 38043
37 Herz-und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen Germany
38 Universitaetsklinikum Schleswig-Holstein Lübeck Germany D-23538
39 Queen Mary Hospital Hong Kong Hong Kong
40 Prince of Wales Hospital Sha Tin Hong Kong
41 Maria Cecilia Hospital SPA Cotignola Italy
42 Erasmus MC- University Medical Center Rotterdam Rotterdam Netherlands 3015 CE
43 Taipei Veterans General Hospital Taipei Beitou District Taiwan 11217
44 National Taiwan University Hospital Taipei City Zhongzheng Dist Taiwan 10002

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

  • Study Chair: Kenneth Ellenbogen, MD, VCU Pauley Heart Center, Richmond, Virginia, USA
  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT04133168
Other Study ID Numbers:
  • PY004
First Posted:
Oct 21, 2019
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Boston Scientific Corporation
cryoablation
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Aug 25, 2022