Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation

Not Applicable

• Conditions: Atrial Fibrillation; CryoAblation; Pulmonary Vein Isolation
• Interventions: Procedure: Wide area circumferential ablation; Procedure: Cryoballoon ablation

• Registration Number: NCT03564925
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

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 Timeline

• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-19
• Study Start: 2019-06-01
• Primary Completion: 2020-10-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wide area circumferential ablation	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.
Cryoballoon ablation	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.

Primary Outcome Measures

Name	Time	Method
Time to first documented recurrence of atrial arrhythmias	12 months	a blanking period of three months will be maintained after the initial procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affilliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China