Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-27 @ 9:09 PM
Study NCT ID:
NCT01401361
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter
Status:
COMPLETED
Status Verified Date:
2019-01
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:
CONTACT_AFL
Brief Summary:
To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter
* Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
* Does not affect efficacy of the ablation procedure The study will also evaluate the
* Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
* Does not affect efficacy of the ablation procedure The study will also evaluate the
Detailed Description:
This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study
1. Validation of ECI against conventional methods of assessing tip tissue contact and
2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
* ECG
* Query regarding adverse events since the last visit
* Assessment of anti-arrhythmic and anti-coagulation medication
* Query regarding recurrence or repeat ablation for typical atrial flutter
1. Validation of ECI against conventional methods of assessing tip tissue contact and
2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:
* ECG
* Query regarding adverse events since the last visit
* Assessment of anti-arrhythmic and anti-coagulation medication
* Query regarding recurrence or repeat ablation for typical atrial flutter
Study Oversight
Has Oversight DMC:
True
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?: