Ignite Creation Date:
2024-05-05 @ 9:27 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00889681
Status:
COMPLETED
Last Update Posted:
2018-09-19
First Post:
2009-04-24
Brief Title:
Continued Access Protocol
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
CAP-AF Continued Access Protocol for the Evaluation 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:
CAP-AF
Brief Summary:
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front Cryoablation System is under review This study will also allow collection of additional safety data following modifications implemented into the Arctic Front Catheter and Cryoablation System
Detailed Description:
1 To evaluate the safety of treatment with the Arctic Front Cardiac CryoAblation Catheter System including the Freezor MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events CPEs and Major Atrial Fibrillation Events MAFEs in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs AFDs
2 To evaluate the effectiveness of treatment with the Arctic Front Cardiac CryoAblation Catheter System including the Freezor MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success LTCS in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs AFDs
3 To evaluate the acute performance of the modified Arctic Front Cardiac CryoAblation Catheter System for comparison with the Arctic Front Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial
2 To evaluate the effectiveness of treatment with the Arctic Front Cardiac CryoAblation Catheter System including the Freezor MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success LTCS in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs AFDs
3 To evaluate the acute performance of the modified Arctic Front Cardiac CryoAblation Catheter System for comparison with the Arctic Front Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial
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