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Cryoablation

Boston Scientific Cardiac Cryoablation System for 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

FROZEN-AF Trial Summary

This trial is testing a new heart treatment for people with a certain kind of irregular heartbeat that doesn't respond to medication.

Eligible Conditions
  • Atrial Fibrillation

FROZEN-AF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Percentage of Participants With Freedom From Recurrence

FROZEN-AF 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
720 Previous Clinical Trials
932,569 Total Patients Enrolled
70 Trials studying Atrial Fibrillation
28,053 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
~93 spots leftby May 2025
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