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Cryoablation

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

N/A
Waitlist Available
Led By Niraj Varma, MD, PhD, FRCP
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a device that uses extreme cold to treat patients with a specific type of irregular heartbeat that doesn't improve with medication. The device works by freezing the veins in the heart that cause the problem.

Eligible Conditions
  • Atrial Fibrillation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
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
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
+1 more
Secondary study objectives
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
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
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
+1 more
Other study objectives
Percentage of Participants With Freedom From Recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CryoablationExperimental Treatment1 Intervention
Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Boston Scientific Cardiac Cryoablation System
2020
N/A
~860

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
744 Previous Clinical Trials
857,342 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
33,632 Patients Enrolled for Atrial Fibrillation
Niraj Varma, MD, PhD, FRCPPrincipal InvestigatorCleveland Clinic, Cleveland OH, USA
Wilber W Su, MD, FACC, FHRSPrincipal InvestigatorBanner- University Medical Group- Heart Center, Phoenix, AZ, USA
Suneet Mittal, MD, FACC, FHRSPrincipal InvestigatorSnyder AF Center, New York, NY, USA
Nassir Marrouche, MDPrincipal InvestigatorUniversity of Utah School of Medicine. Slat Lake City, UT, USA
6 Previous Clinical Trials
610 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
210 Patients Enrolled for Atrial Fibrillation
Suneet Mittal, MD,FACC,FHRSPrincipal InvestigatorSnyder AF Center, New York, NY, USA
Wilber W Su, MD,FACC,FHRSPrincipal InvestigatorBanner- University Medical Group- Heart Center, Phoenix, AZ, USA
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
200 Patients Enrolled for Atrial Fibrillation
Arash Aryana, MD, PhDPrincipal InvestigatorMercy General Hospital,Sacramento, CA , USA
1 Previous Clinical Trials
1,784 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,784 Patients Enrolled for Atrial Fibrillation
Niraj Varma, MD,PhD,FRCPPrincipal InvestigatorCleveland Clinic, Cleveland OH, USA
Kenneth Ellenbogen, MDStudy ChairVCU Pauley Heart Center, Richmond, Virginia, USA
5 Previous Clinical Trials
820 Total Patients Enrolled
3 Trials studying Atrial Fibrillation
577 Patients Enrolled for Atrial Fibrillation
~85 spots leftby Dec 2025
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