Using Cryoballoon Ablation as Initial Treatment for Persistent Atrial Fibrillation

NCT04942834 | Unknown

• 1 other identifier: Cryo-initial-AF
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 17

Brief Summary

This study is to assess the effectiveness and safety of using cryoballoon ablation comparing with anti-arrhythmic drug therapy as initial treatment for naive patients with persistent atrial fibrillation.

Conditions

Atrial Fibrillation, Persistent; Arrhythmias, Cardiac

Keywords

cryoablation; pulmonary vein isolation; atrial fibrillation; Anti-Arrhythmic Agents

Outcome Measures

Primary Outcomes (2)

• Treatment success at 12 months

  Treatment success at 12 months after antiarrhythmic drug (AAD) initiation or ablation utilizing cryoballoon catheter measured by freedom from AF recurrence following a 3-month period after the index ablation or AAD initiation.

  Randomization to 12 months

• Rate of serious adverse events

  Rate of serious procedure-related and serious cryoablation system-related reported adverse events through 12 months after the index ablation procedure

  Randomization to 12 months

Secondary Outcomes (4)

• Quality of life changes at 12 months measured by AFEQT

  one year

• Quality of life changes at 12 months measured by SF-12

  one year

• Arrhythmia recurrence during blanking period

  3 months

• time to first time cardiovascular hospitalization (month)

  one year

Study Arms (2)

Drug treatment group

ACTIVE COMPARATOR

receive class I or class III AAD to restore or maintain sinus rhythm.

Drug: Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone

cryoballoon ablation group

EXPERIMENTAL

receive cryoballoon ablation to restore sinus rhythm.

Device: cryoballoon ablation

Interventions

Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone DRUG

Class I or III antiarrhythmic drug, including sotalol

Drug treatment group

cryoballoon ablation DEVICE

Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)

cryoballoon ablation group

Eligibility Criteria

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

You may qualify if:

• Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by consecutive ECG recordings OR Defined as having a continuous episode lasting longer than 7 days but less than 1 year documented by an ECG recording and one doctor note indicating patient had symptoms consistent with AF
• Age 18 -75 years old
• Structurally normal heart with LVEF ≥50%, interventricular septum thickness ≤ 12 mm, and left atrial diameter \<46 mm (short axis) as obtained by transthoracic echocardiography. •
• Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms in a 12-channel surface ECG, QTc interval \<440 ms, and PQ interval ≤210 ms).

You may not qualify if:

• History of AF treatment with class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days with the intention to convert an AF episode are allowed.
• left atrial ablation or surgical procedure (including left atrial appendage closures)
• Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Presence of any cardiac valve prosthesis
• +3 and +4 mitral valve regurgitation or stenosis
• Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding e consent date
• Unstable angina
• New York Heart Association (NYHA) Class II, III or IV congestive heart failure
• Primary pulmonary hypertension
• Rheumatic heart disease
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (17)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Dongguan People's Hospital

Dongguan, Guangdong, 523018, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 511466, China

RECRUITING

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, 561113, China

RECRUITING

Nanjing Drum Tower hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Affiliated Hospital Of Nantong University

Nantong, Jiangsu, 226019, China

RECRUITING

Jiangsu Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

RECRUITING

Qilu Hospital Of Shandong University

Jinan, Shangdong, 250012, China

RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

"West China School of Medicine /West China Hospital of Sichuan University "

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300022, China

RECRUITING

The Second Hospital Of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Sotalol; Dronedarone; Amiodarone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Li-qun Wu, MD,PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-qun Wu, MD,PhD

CONTACT

+8613801621534; wuliqun89@hotmail.com

Yangyang Bao, MD,PhD

CONTACT

+8613301687572; 575525677@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 29, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 26, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)