Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01604369
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2012-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cryoablation as Standard Treatment of Atrial Flutter
Sponsor:
Karolinska University Hospital
Organization:
Study Overview
Official Title:
Cryoablation as Standard Treatment of Atrial Flutter - Long Term Efficacy and Patient Content
Status:
COMPLETED
Status Verified Date:
2016-10
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:
CASTAF
Brief Summary:
The hypothesis of the present study is to evaluate cryoablation(cooling of the tissue) as standard therapy of common atrial flutter,focusing on efficacy, feasibility, procedure time, and patient content.
The purpose of this study is to determine whether cryoablation, performed only by operators experienced in cryothermic ablation is effective and safe in the treatment of atrial flutter.
The purpose of this study is to determine whether cryoablation, performed only by operators experienced in cryothermic ablation is effective and safe in the treatment of atrial flutter.
Detailed Description:
Atrial flutter (AFL), a common atrial tachyarrhythmia may cause significant symptoms and serious adverse effects including embolic stroke, myocardial ischemia and congestive heart failure. Currently, radiofrequency (RF) catheter ablation of the cavotricuspid isthmus (CTI) is considered first-line therapy for treatment of CTI-dependent AFL. However, RF ablation of the CTI is associated with significant pain during lesion delivery. Furthermore, RF ablation can potentially injure cardiac structures adjacent to the CTI such as the AV node, tricuspid valve and right coronary artery. RF ablation can also lead to steam pops, cardiac tamponade and fatal complications have also been reported in association with CTI-ablation. Ablation using cryothermal energy (Cryo) has several potential advantages over RF ablation including greater catheter stability due to adherence to myocardial tissue during applications, reduced risk of thrombus formation, systemic embolization, and lower risk of myocardial perforation due to preservation of tissue architecture.
The investigators have in a prospective randomized, single centre study (CRAFT) investigated efficacy and safety of RF versus Cryo for atrial flutter, and showed that cryoablation is as effective as RF ablation in the short and long term. The patients perceived significantly less pain and required significantly lower doses of analgesia and sedation during cryoablation compared to RF ablation. The study was powered for non-inferiority with 75 patients in each group.
The objective of the present study is to expand the findings from the CRAFT study in a larger cohort of patients, letting only operators experienced in cryothermic CTI ablation use Cryo as standard therapy focusing on efficacy, feasibility, procedure time, and patient content.
To perform an ablation within the study, the electrophysiologist must have a previous experience of a minimum of 25 cryoablations of atrial flutter.
The investigators have in a prospective randomized, single centre study (CRAFT) investigated efficacy and safety of RF versus Cryo for atrial flutter, and showed that cryoablation is as effective as RF ablation in the short and long term. The patients perceived significantly less pain and required significantly lower doses of analgesia and sedation during cryoablation compared to RF ablation. The study was powered for non-inferiority with 75 patients in each group.
The objective of the present study is to expand the findings from the CRAFT study in a larger cohort of patients, letting only operators experienced in cryothermic CTI ablation use Cryo as standard therapy focusing on efficacy, feasibility, procedure time, and patient content.
To perform an ablation within the study, the electrophysiologist must have a previous experience of a minimum of 25 cryoablations of 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?: