Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation

NCT03564925 | Unknown DMC

• 1 other identifier: WACACF vs Cryo
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; CryoAblation; Pulmonary Vein Isolation

Keywords

Atrial Fibrillation; CryoAblation; pulmonary vein isolation; wide area circumferential ablation; contact force

Outcome Measures

Primary Outcomes (1)

• Time to first documented recurrence of atrial arrhythmias

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

  12 months

Secondary Outcomes (10)

• time to the first occurrence of each of the components of the primary outcome

  12 months

• all-cause death

  12 months

• Arrhythmia-related death

  12 months

• total procedural duration

  12 months

• total time of fluoroscopy

  12 months

Study Arms (2)

Wide area circumferential ablation

ACTIVE COMPARATOR

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.

Procedure: Wide area circumferential ablation

Cryoballoon ablation

EXPERIMENTAL

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.

Procedure: Cryoballoon ablation

Interventions

Wide area circumferential ablation PROCEDURE

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

Wide area circumferential ablation

Cryoballoon ablation PROCEDURE

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.

Cryoballoon ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ≥ 18 and ≤ 75 years of age.
• Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
• 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.

You may not qualify if:

• Patients with prosthetic valves.
• Any previous LA ablation or surgery.
• Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
• Unstable angina pectoris.
• Myocardial infarction within three months prior to enrollment.
• Symptomatic carotid stenosis.
• Chronic obstructive pulmonary disease with detected pulmonary hypertension.
• Any condition contraindicating chronic anticoagulation.
• Stroke or transient ischemic attack within six months prior to enrollment.
• Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
• New York Heart Association (NYHA) class III or IV congestive heart failure.
• EF \< 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
• Anteroposterior LA diameter \> 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
• LA thrombus (TEE diagnostic performed on admission). Intracardiac thrombus.
• PV diameter \> 26 mm in right sided PVs.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affilliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• 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.

  PMID: 27042964 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ZHIYU LING, MD

CONTACT

+8613512362075; lingzy1977@163.com

YANPING XU, MD

CONTACT

+86-23-63693079

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

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

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: June 21, 2018
• Study Start: June 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 30, 2021
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)