Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation (WACACF vs Cryo)

• ClinicalTrials.gov Identifier: NCT03564925
• Recruitment Status: Unknown
• First Posted: June 21, 2018
• Last Update Posted: March 19, 2019
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Information provided by (Responsible Party): Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

Tracking Information

• First Submitted Date: September 10, 2017
• First Posted Date: June 21, 2018
• Last Update Posted Date: March 19, 2019
• Estimated Study Start Date: June 1, 2019
• Estimated Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 20, 2018)

Time to first documented recurrence of atrial arrhythmias [ Time Frame: 12 months ]

a blanking period of three months will be maintained after the initial procedure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 20, 2018)

• time to the first occurrence of each of the components of the primary outcome [ Time Frame: 12 months ]
  a blanking period of three months will be maintained after the initial procedure
• all-cause death [ Time Frame: 12 months ]
  all-cause death
• Arrhythmia-related death [ Time Frame: 12 months ]
  Arrhythmia-related death
• total procedural duration [ Time Frame: 12 months ]
  time of total procedural
• total time of fluoroscopy [ Time Frame: 12 months ]
  total time of fluoroscopy
• time to recurrent atrial fibrillation (AF) [ Time Frame: 12 months ]
  a blanking period of three months will be maintained after the initial procedure
• time to first cardiovascular hospitalization [ Time Frame: 12 months ]
  a blanking period of three months will be maintained after the initial procedure
• number of cardiovascular hospitalizations (over-night stays) [ Time Frame: 12 months ]
  a blanking period of three months will be maintained after the initial procedure
• quality of life changes at 12 months compared to baseline [ Time Frame: 12 months ]
  with the evaluation of the MOS item short from health survey（SF-36）
• time to first symptomatic AF recurrence [ Time Frame: 12 months ]
  a blanking period of three months will be maintained after the initial procedure

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

two groups, group one is for Wide Area Circumferential Ablation With Contact Force catheter, group two is for Cryoballoon Ablation

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Atrial Fibrillation
• CryoAblation
• Pulmonary Vein Isolation

Intervention

• Procedure: Wide area circumferential ablation
  Wide area circumferential ablation with contact force catheter will be performed in Patients allocated in this group,the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing will be performed. If frequent atrial premature beats are found beyond pulmonary vein, activation mapping will be performed for eliminating the triggers. If atrial tachycardias(ATs)are induced, activation mapping the ATs and ablation will be performed. Electrical isolation of pulmonary veins and elimination the triggers and ATs induced by isoproterenol or programmed stimulation and burst pacing are the endpoints of ablation
• Procedure: Cryoballoon ablation
  In the cryoballoon procedures, pulmonary vein isolation (PVI) was achieved using fluoroscopic guidance to position the cryoballoon catheter. Once PV-to-balloon occlusion was confirmed by retrograde radiopaque contrast agent retention, circumferential ablation was performed by freezing with a single-shot delivery of coolant to the balloon.

Study Arms

• Active Comparator: Wide area circumferential ablation
  Device:Smart Touch® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
  Intervention: Procedure: Wide area circumferential ablation
• Experimental: Cryoballoon ablation
  Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
  Intervention: Procedure: Cryoballoon ablation

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 20, 2018): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2021
• Estimated Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03564925
• Other Study ID Numbers: WACACF vs Cryo
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: The Second Affiliated Hospital of Chongqing Medical University
• Verification Date: March 2019