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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
718 Previous Clinical Trials
932,490 Total Patients Enrolled
68 Trials studying Atrial Fibrillation
27,830 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many localities are encompassed by this research endeavor?

"This trial is recruiting patients across 15 different medical centres, including Christus Trinity Mother Frances Health System in Tyler, Kettering Medical Center in Kettering and St. Joseph's Hospital in Tampa."

Answered by AI

Are any new volunteers being sought for this research endeavor?

"According to the records present on clinicaltrials.gov, this trial is no longer actively recruiting patients as its last update was made on November 14th 2022. However, 476 other medical studies are currently enrolling volunteers across various locations."

Answered by AI

What are the core aims of this clinical experimentation?

"Per the trial sponsor, Boston Scientific Corporation, the primary purpose of this research is to measure Rate of Primary Safety Events at 12 Months post-procedure (acute and chronic events) when utilizing their Cardiac Cryoablation system with POLARx cryoablation balloon catheter models. Secondary objectives include gauging Acute Procedural Success defined as electrical isolation of all PVs by using said equipment, ascertaining reportable Adverse Events at 12 months post procedure, assessing Safety Events at 12 months post procedure utilising Boston Scientific's Cardiac Cryoablation System with POLARx FIT cryoballoon cat"

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Kettering Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

Screening procedures? How long is the process?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Local cardiologist has been trying different medications to help with this condition. Running out of medication options.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Most responsive sites:
  1. Kettering Medical Center: < 24 hours
Recent research and studies
clinicaltrials.govStudy
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
2020. "Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04133168.
~96 spots leftby Apr 2025
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