Cryoablation as Standard Treatment of Atrial Flutter (CASTAF)
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Medtronic Freezor Max Cardiac Cryoablation Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial flutter, Cryoablation, Cavotricuspid isthmus, Visual analogue scale
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients referred to our institution for ablation therapy of ECG-documented, typical CTI dependent AFL.
- Patients above the age of 18 having symptomatic CTI-dependent AFL documented on a 12-lead ECG with typical ECG appearance of negative saw tooth waves in the inferior limb leads and positive deflections in V1 or positive saw tooth waves in the inferior limb leads and negative deflections in V1.
- Patients with a history of atrial fibrillation will only be included if they have predominant atrial flutter under chronic treatment with class I or III antiarrhythmic agents.
Exclusion Criteria:
- prior ablation for AFL;
- atrial flutter related to recently undergone surgery, hyperthyroidism or other severe disease;
- inability to adhere with the study protocol;
- pregnancy;
- predominant atrial fibrillation; and
- for patients with persistent atrial flutter contraindication to warfarin
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryoablation
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Clinical success defined as the freedom from atrial flutter evaluated at the 12-month follow-up.
Secondary Outcome Measures
Safety
The secondary endpoints will be acute ablation success defined as bidirectional CTI-block, safety assessed by the rate of periprocedural complications, procedure and fluoroscopy times and the level of pain experienced by the patient during the ablation procedure.
Full Information
NCT ID
NCT01604369
First Posted
May 21, 2012
Last Updated
October 5, 2016
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01604369
Brief Title
Cryoablation as Standard Treatment of Atrial Flutter
Acronym
CASTAF
Official Title
Cryoablation as Standard Treatment of Atrial Flutter - Long Term Efficacy and Patient Content
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Atrial flutter, Cryoablation, Cavotricuspid isthmus, Visual analogue scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryoablation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Medtronic Freezor Max Cardiac Cryoablation Catheter
Other Intervention Name(s)
Cryoablation, CTI ablation
Intervention Description
Cryoablation is performed using a sequential application technique point-by-point from the tricuspid annulus to the inferior vena cava. Ablation is performed at a target temperature of -80 ºC. Each application will last for 240 seconds.
Primary Outcome Measure Information:
Title
Efficacy
Description
Clinical success defined as the freedom from atrial flutter evaluated at the 12-month follow-up.
Time Frame
One year after intervention
Secondary Outcome Measure Information:
Title
Safety
Description
The secondary endpoints will be acute ablation success defined as bidirectional CTI-block, safety assessed by the rate of periprocedural complications, procedure and fluoroscopy times and the level of pain experienced by the patient during the ablation procedure.
Time Frame
During and up to one year after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive patients referred to our institution for ablation therapy of ECG-documented, typical CTI dependent AFL.
Patients above the age of 18 having symptomatic CTI-dependent AFL documented on a 12-lead ECG with typical ECG appearance of negative saw tooth waves in the inferior limb leads and positive deflections in V1 or positive saw tooth waves in the inferior limb leads and negative deflections in V1.
Patients with a history of atrial fibrillation will only be included if they have predominant atrial flutter under chronic treatment with class I or III antiarrhythmic agents.
Exclusion Criteria:
prior ablation for AFL;
atrial flutter related to recently undergone surgery, hyperthyroidism or other severe disease;
inability to adhere with the study protocol;
pregnancy;
predominant atrial fibrillation; and
for patients with persistent atrial flutter contraindication to warfarin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mats Jensen-Urstad, Professor
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-14186
Country
Sweden
12. IPD Sharing Statement
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Cryoablation as Standard Treatment of Atrial Flutter
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