Status:
COMPLETED
Cryoballoon Ablation as First Line Treatment of Atrial Flutter
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborating Sponsors:
Medtronic International Trading Sarl
Conditions:
Atrial Flutter Typical
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Current guidelines recommend radiofrequency catheter ablation of the cavotricuspid isthmus as treatment for symptomatic/drug-refractory atrial flutter, in spite of the fact that recurrences of flutter...
Detailed Description
Atrial flutter and atrial fibrillation are believed to share the same initiating triggers in the form of pulmonary vein ectopy. Cavo-tricuspid isthmus-dependent atrial flutter almost always results fr...
Eligibility Criteria
Inclusion
- 1\. Age 18-80 years
- 2\. Patients referred for catheter ablation for typical atrial flutter. The atrial flutter may be either persistent or paroxysmal, with at least one episode having been documented on 12-lead ECG. In the view of the treating physician, the ECG morphology should be compatible with a CTI-dependent circuit, either counterclockwise or clockwise.
Exclusion
- 1\. Any evidence of previously documented atrial fibrillation
- 2\. Previous cavo-tricuspid isthmus ablation or atrial fibrillation ablation
- 3\. Atrial flutter documented solely on Ambulatory monitoring
- 4\. Atrial flutter morphology on ECG suggestive of a left atrial flutter
- 5\. History of atrial flutter with 1:1 atrioventricular conduction and haemodynamic compromise
- 6\. Indwelling atrial-septal defect occluder device, or any anatomical reason that precludes left atrial access
- 7\. Left atrial diameter (PLAX M-mode) \>5.5 cm
- 8\. Severe left ventricular dysfunction (LV ejection fraction \< 30% on Echocardiography)
- 9\. Recent stroke/transient ischaemic attack within 3 months
- 10\. Inability or unwillingness to take oral anticoagulant treatment
- 11\. Morbid obesity (Body Mass Index ≥40)
- 12\. Extreme frailty (A score of 7,8 or worse on the Clinical Frailty Scale)
- 13\. Implanted metal prosthetic valve(s) in mitral position
- 14\. Indwelling cardiac resynchronisation therapy device, pacemaker or implantable cardioverter defibrillator
- 15\. Advanced Renal dysfunction (eGFR\<30 ml/min)
- 16\. Pregnancy
- 17\. Severe valvular heart disease of any kind as assessed by the investigator
- 18\. Previous valve replacement surgery or other prosthetic heart valve
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03401099
Start Date
August 17 2018
End Date
November 1 2023
Last Update
November 13 2023
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Basel
Basel, Switzerland
2
University Hospital Inselspital Bern
Bern, Switzerland
3
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridge, United Kingdom, CB23 3RE
4
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom