Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523978
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2007-08-31
Brief Title:
A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
A Randomized Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stop-AF
Brief Summary:
This study STOP AF is a prospective randomized controlled multicenter pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada Subjects with paroxysmal atrial fibrillation PAF referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation AF Drugs flecainide propafenone or sotalol were randomized 21 to cryoablation intervention Experimental Subjects ES or to a Study AF Drug Control Subjects CS Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms weekly scheduled trans-telephonic monitoring patient-initiated trans-telephonic monitoring and 24-hour Holter monitoring at 6 and 12 months The first 90 days after study therapy was initiated was considered a blanked period for all subjects
Detailed Description:
STOP AF PS-023 is a randomized controlled study of subjects 18 to 75 years old who had been referred for ablative intervention after failing one or two but not all three anti-arrhythmic drugs used in the treatment of AF flecainide propafenone and sotalol Study subjects were randomized into two arms the cryoablation treatment arm and the membrane-active antiarrhythmic drug control arm A 90- day blanked follow-up period including reablation and medication adjustments was applied in both arms to optimize therapies All subjects underwent follow-up assessments at 1 3 6 9 and 12 months weekly transtelephonic monitoring 24-hour Holter monitoring and CTMRI of the pulmonary veinsat 6 and 12 months during the trial period Control subjects who were confirmed to be chronic treatment failures were permitted to crossover to cryoablation in this trial
Acute procedural success was defined for subjects that underwent cryoablation and demonstrated electrical isolation in 3 Pulmonary Veins PVs at the conclusion of the first protocol-defined cryoablation procedure using the Arctic Front Cardiac CryoAblation Catheter System
The primary effectiveness endpoint was defined as having acute procedural success and freedom from chronic treatment failure CTF for experimental subjects and freedom from CTF for control subjects Freedom from CTF was defined for both groups as the occurrence of detectable AF during a non-blanked follow-up period or an AF Intervention or the use of a non-study AF drug at any time
The co-primary safety outcome measures were Cryoablation Procedure Events CPEs in cryoablated subjects and Major Atrial Fibrillation Events MAFEs in both groups CPEs were device- or procedure-related serious adverse events
Other safety assessments were made during the course of the STOP AF trial specific to pulmonary vein stenosis PVS and phrenic nerve injury
Acute procedural success was defined for subjects that underwent cryoablation and demonstrated electrical isolation in 3 Pulmonary Veins PVs at the conclusion of the first protocol-defined cryoablation procedure using the Arctic Front Cardiac CryoAblation Catheter System
The primary effectiveness endpoint was defined as having acute procedural success and freedom from chronic treatment failure CTF for experimental subjects and freedom from CTF for control subjects Freedom from CTF was defined for both groups as the occurrence of detectable AF during a non-blanked follow-up period or an AF Intervention or the use of a non-study AF drug at any time
The co-primary safety outcome measures were Cryoablation Procedure Events CPEs in cryoablated subjects and Major Atrial Fibrillation Events MAFEs in both groups CPEs were device- or procedure-related serious adverse events
Other safety assessments were made during the course of the STOP AF trial specific to pulmonary vein stenosis PVS and phrenic nerve injury
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None