Atrial Fibrillation Clinical Trial
— WACACF vs CryoOfficial title:
Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 30, 2021 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months). Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including ß-blocker and AAD intolerance). 2. = 18 and = 75 years of age. 3. Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol. 4. Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial. Exclusion Criteria: Exclusion criteria related to a cardiac condition 1. Patients with prosthetic valves. 2. Any previous LA ablation or surgery. 3. Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment. 4. Unstable angina pectoris. 5. Myocardial infarction within three months prior to enrollment. 6. Symptomatic carotid stenosis. 7. Chronic obstructive pulmonary disease with detected pulmonary hypertension. 8. Any condition contraindicating chronic anticoagulation. 9. Stroke or transient ischemic attack within six months prior to enrollment. 10. Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale. 11. New York Heart Association (NYHA) class III or IV congestive heart failure. 12. EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history). 13. Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment). 14. LA thrombus (TEE diagnostic performed on admission). Intracardiac thrombus. 15. PV diameter > 26 mm in right sided PVs. 16. Mitral prosthesis. 17. Hypertrophic cardiomyopathy 18. 2° (Type II) or 3° atrioventricular block. 19. Brugada syndrome or long QT syndrome. 20. Arrhythmogenic right ventricular dysplasia. 21. Sarcoidosis. 22. PV stent. 23. Myxoma. Exclusion criteria based on laboratory abnormalities 1. Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl). 2. Any untreated or uncontrolled hyperthyroidism or hypothyroidism. 3. Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min). |
Country | Name | City | State |
---|---|---|---|
China | The Second Affilliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Chongqing Medical University |
China,
Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first documented recurrence of atrial arrhythmias | a blanking period of three months will be maintained after the initial procedure | 12 months | |
Secondary | time to the first occurrence of each of the components of the primary outcome | a blanking period of three months will be maintained after the initial procedure | 12 months | |
Secondary | all-cause death | all-cause death | 12 months | |
Secondary | Arrhythmia-related death | Arrhythmia-related death | 12 months | |
Secondary | total procedural duration | time of total procedural | 12 months | |
Secondary | total time of fluoroscopy | total time of fluoroscopy | 12 months | |
Secondary | time to recurrent atrial fibrillation (AF) | a blanking period of three months will be maintained after the initial procedure | 12 months | |
Secondary | time to first cardiovascular hospitalization | a blanking period of three months will be maintained after the initial procedure | 12 months | |
Secondary | number of cardiovascular hospitalizations (over-night stays) | a blanking period of three months will be maintained after the initial procedure | 12 months | |
Secondary | quality of life changes at 12 months compared to baseline | with the evaluation of the MOS item short from health survey(SF-36) | 12 months | |
Secondary | time to first symptomatic AF recurrence | a blanking period of three months will be maintained after the initial procedure | 12 months |
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