CAB Versus Medical Therapy in Patients With AF and HF With Different EF Categories

Cryoballoon Ablation Versus Medical Therapy in Patients With Atrial Fibrillation and Heart Failure With Different Ejection Fraction Categories

This study is to assess the effectiveness and safety of cryoballoon ablation comparing with medical therapy in patients with atrial fibrillation and heart failure with different ejection fraction categories.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Antiarrhythmic drug Therapy; Device: cryoballoon ablation

Detailed Description

Subjects with atrial fibrillation and heart failure with different ejection fraction categories are devided to either an anti-arrhythmic drug or cryoballoon catheter ablation.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Qi Lu, MD; Phone Number: +8613962989292; Email: luqint@sina.com
• Study Contact Backup: Name: Haixia Xu, MD; Phone Number: +8615050641838; Email: ntxhx2005@163.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Qi Lu, Dr.; Phone Number: 13962989292; Email: luqint@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.

Description

Inclusion Criteria:

• Diagnosed with symptomatic paroxysmal or persistent atrial fibrillation：defined as at least two symptomatic episodes in the last six months prior to enrollment.
• At least 18 years old and not older than 80 years old.
• Able and willing to give informed consent.

Exclusion Criteria:

• History of AF treatment with class I or III AAD, 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.
• Previous left atrial ablation.
• Previous cardiac surgery including prosthetic valves.
• Permanent pacemaker or defibrillator implant.
• Second degree type II or third degree AV-block or a pattern of left/right bundle branch block.
• History of previous myocardial infarction or percutaneous intervention during the last 3 months.
• Any history of previous transient ischemic attack, prolonged reversible ischemic neurological deficit, and/or stroke.
• Known intracardiac thrombus formation.
• Pulmonary vein stent.
• Known cryoglobulinaemia.
• Active systemic infection.
• Hypertrophic cardiomyopathy.
• Life expectancy is ≤1 year.
• Reversible cause of atrial fibrillation (eg, hyperthyroidism or alcoholism).
• Abnormal long or short QT intervals, signs of Brugada syndrome, known family history of inherited ion channel disease, and/or arrhythmogenic right ventricular dysplasia.
• Chronic obstructive pulmonary disease with detected pulmonary hypertension and/or any other evidence of significant lung disease.
• Contraindication for oral anticoagulation.
• Pregnant women or woman of childbearing potential with inadequate birth control.
• Women who are breastfeeding.
• Any significant congenital heart defect corrected or not corrected; however, patent foramen ovale is allowed.
• Thrombocytosis (platelet count > 600,000/μL) or thrombocytopenia (platelet count < 100,000/μL).
• Untreated or uncontrolled hyperthyroidism or hypothyroidism.
• Renal dysfunction with glomerular filtration rate < 60 mL/min.
• Unstable angina pectoris.
• Symptomatic carotid stenosis.
• Myxoma based on laboratory abnormalities.
• Sarcoidosis.
• Unwilling to unable to comply with the study procedure and follow-up schedule due to any disease condition.
• Legal incapacity or evidence that the patient cannot understand the purpose and risks of the study, including inability to comply fully with study procedures and follow-up.
• Employed by Medtronic, or the department of an investigator, or close-familial relative of an investigator.
• Enrolled or planning to participate in a potentially confounding drug or device trial during this study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medical treatment group; Using class I or class III AAD to maintain sinus rhythm	Drug: Antiarrhythmic drug Therapy; Propafenone, Sotalol and Amiodarone; Other Names: Class I or III antiarrhythmic drug
Cryoballoon ablation group; Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)	Device: cryoballoon ablation; Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success at one year	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.	one year
Rate of adverse events	Rate of complications and adverse events occurred during cryoballoon ablation and postoperative follow-up, including all-cause mortality, rehospitalisation for HF, and the composite event of all-cause mortality or HF hospitalisation	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia recurrence during blanking period	atrial tachycardia recurrence	3 months
Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12)	The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by 12-Item Short Form Survey (SF-12) with the values ranging from 12 - 47 (higher scores mean a worse outcome)	one year
Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)	The improvement in quality of life between baseline and 12 months after the index ablation procedure or AAD measured by AF Quality of Life Survey (AFEQT) with the values ranging from 20 - 140 (higher scores mean a worse outcome)	one year

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Anti-Arrhythmia Agents
• Other Study ID Numbers: 2022-K039-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No