Clinical trial NCT03564925: Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation
Official title: Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
CryoAblation
Pulmonary Vein Isolation
Keywords: Atrial Fibrillation
CryoAblation
pulmonary vein isolation
wide area circumferential ablation
contact force
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups, group one is for Wide Area Circumferential Ablation With Contact Force catheter, group two is for Cryoballoon Ablation
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with stroke, reductions in quality of life and overall survival. Previous studies have shown that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation. However, the pulmonary vein isolation for radiofrequency catheter ablation in previous studies was done around each pulmonary-vein antrum, and it's not wide area circumferential ablation. Moreover, the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing was not performed in most of previous studies. We hypothesize that wide area circumferential ablation with contact force catheter and combined catheter ablation the potential atrial triggers and/or other atrial arrhythmias induced by aggressive induction is more effective than cryoballoon ablation in patients with paroxysmal atrial fibrillation.

Eligibility criteria: 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 β-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).

Primary outcomes:
measure: Time to first documented recurrence of atrial arrhythmias
timeFrame: 12 months
Secondary outcomes:
measure: time to the first occurrence of each of the components of the primary outcome
timeFrame: 12 months
measure: all-cause death
timeFrame: 12 months
measure: Arrhythmia-related death
timeFrame: 12 months
measure: total procedural duration
timeFrame: 12 months
measure: total time of fluoroscopy
timeFrame: 12 months
measure: time to recurrent atrial fibrillation (AF)
timeFrame: 12 months
measure: time to first cardiovascular hospitalization
timeFrame: 12 months
measure: number of cardiovascular hospitalizations (over-night stays)
timeFrame: 12 months
measure: quality of life changes at 12 months compared to baseline
timeFrame: 12 months
measure: time to first symptomatic AF recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affilliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
citation: Kuck KH, Brugada J, Furnkranz 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;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.