Trial · NCT00523978

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

NCT00523978, Phase 3, Completed, Medtronic Cardiac Rhythm and Heart Failure; results first posted 2012-08-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation. Trials, record NCT00523978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00523978

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
NCT number: NCT00523978
Status: Completed
Phases: Phase 3
Enrollment: 245 participants, actual
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Conditions: Paroxysmal Atrial Fibrillation
Interventions: Arctic Front® Cryoablation Catheter, Flecainide or Sotalol or Propafenone
First posted: 2007-09-03
Last updated: 2018-10-16
Results first posted: 2012-08-28

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Acute Procedural Success (APS)	371.4 Minutes (Average)	Acute Procedural Success was defined as a demonstration of electrical isolation in ≥ 3 Pulmonary Veins (PVs) at the conclusion of the first protocol-defined cryoablation procedure. APS was decided at the end of the procedure the mean time was calculated for the time frame.
Primary	Freedom From Chronic Treatment Failure (CTF)	12 month follow up period	Subjects that did not have or were free of CTF. CTF was defined as the occurence of an Atrial Fibrillation (AF) intervention, use of non-study AF drug therapy, or the occurence of detectable AF which is is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Primary	Treatment Success	12 months	Treatment Success was defined as Acute Procedure Success (APS) and freedom from Chronic Treatment Failure (CTF) for Experimental Subjects, and freedom from CTF for Control Subjects. Under this pre-specified definition of Treatment Success, Experimental Subjects must have had APS and remained free of CTF during the 12-month follow-up duration, while Control Subjects must have remained free of CTF during the 12-month follow-up duration.
Primary	Freedom From Major Atrial Fibrillation Events (MAFEs)	12 Months	Subjects that did not have or were free of MAFEs. MAFEs were serious adverse events categorized as cardiovascular death, myocardial infarction, stroke, or hospitalization for AF recurrence/ablation, flutter ablation, embolic events, heart failure, hemorrhage or anti-arrhythmic drug treatment.
Primary	Cryoablation Procedure Events (CPEs)	To end of ablation procedure	Subjects that had CPEs. CPEs were device- or procedure-related serious adverse events (SAE) categorized as access site complications, cardiac damage, pulmonary vein (PV) stenosis, embolic complications, arrhythmias, unresolved phrenic nerve palsy and death.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Acute Procedural Success (APS)	371.4 Minutes (Average)	Subjects evaluated were from the modified Intent to Treat subset (mITT)or subjects that were enrolled, randomized and received treatment.	participants	NUMBER
PRIMARY	Freedom From Chronic Treatment Failure (CTF)	12 month follow up period	This section includes data for subjects who were randomized, received treatment and were followed through 12-Months post randomized treatment regardless of AF Drug usage. Subjects who experienced Acute Procedural Failure in the Experimental group were not included in this analysis of post-procedural failure causes.	participants	NUMBER
PRIMARY	Treatment Success	12 months	The mITT population consisted of all subjects, who were enrolled, randomized and received treatment	participants	NUMBER
PRIMARY	Freedom From Major Atrial Fibrillation Events (MAFEs)	12 Months	mITT set included all subjects (82 CS, 163 ES) who were enrolled, randomized, and received treatment.	participants	NUMBER
PRIMARY	Cryoablation Procedure Events (CPEs)	To end of ablation procedure	Data for subjects who were randomized to the Experimental group and received cryoablation therapy were included in this analysis. All CPEs reported in the Experimental group were included in the analysis regardless of their association with the first or a repeat cryoablation.	participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Acute Procedural Success (APS)	Cryoablation	160		participants
Freedom From Chronic Treatment Failure (CTF)	Cryoablation	117		participants
Freedom From Chronic Treatment Failure (CTF)	Standard Treatment With Drugs Only	6		participants
Treatment Success	Cryoablation	114	62.3 to 76.9	participants
Treatment Success	Standard Treatment With Drugs Only	6	2.7 to 15.2	participants
Freedom From Major Atrial Fibrillation Events (MAFEs)	Cryoablation	158		participants
Freedom From Major Atrial Fibrillation Events (MAFEs)	Standard Treatment With Drugs Only	75		participants
Cryoablation Procedure Events (CPEs)	Cryoablation	5		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cryoablation	171
Overall Study	STARTED	Standard Treatment With Drugs Only	87
Overall Study	COMPLETED	Cryoablation	162
Overall Study	COMPLETED	Standard Treatment With Drugs Only	79
Overall Study	NOT COMPLETED	Cryoablation	9
Overall Study	NOT COMPLETED	Standard Treatment With Drugs Only	8

Source ClinicalTrials.gov

Adverse events134

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Atrial Fibrillation	Cardiac disorders	Cryoablation	14	163	14
other	Atrial Fibrillation	Cardiac disorders	Standard Treatment With Drugs Only	16	65	16
other	Atrial Flutter	Cardiac disorders	Cryoablation	18	163	18
other	Atrial Flutter	Cardiac disorders	Standard Treatment With Drugs Only	10	65	10
other	Bradycardia	Cardiac disorders	Cryoablation	0	163	0
other	Bradycardia	Cardiac disorders	Standard Treatment With Drugs Only	4	65	4
other	Fatigue	General disorders	Cryoablation	12	163	12
other	Fatigue	General disorders	Standard Treatment With Drugs Only	9	65	9
other	Chest Pain	General disorders	Cryoablation	9	163	9
other	Chest Pain	General disorders	Standard Treatment With Drugs Only	4	65	4

1 to 10 of 134Source ClinicalTrials.gov

See all 134 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cryoablation
Total, all-cause mortality	Standard Treatment With Drugs Only
Total, other adverse events	Cryoablation	19	163
Total, other adverse events	Standard Treatment With Drugs Only	16	65
Total, serious adverse events	Cryoablation	20	163
Total, serious adverse events	Standard Treatment With Drugs Only	12	82

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23500312	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cryoablation vs Standard Treatment With Drugs Only: Freedom From Major Atrial Fibrillation Events (MAFEs)	Trial comparisons
Cryoablation vs Standard Treatment With Drugs Only: Treatment Success	Trial comparisons
Cryoablation vs Standard Treatment With Drugs Only: Freedom From Chronic Treatment Failure (CTF)	Trial comparisons
Cryoablation vs Standard Treatment With Drugs Only: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00523978

GET https://conductscience.org/api/trials/v1/NCT00523978/events?page=2

API reference For AI assistants