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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364866
• Other study ID #: 2022-K039-01
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Qi Lu, MD
• Phone: +8613962989292
• Email: luqint[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• Antiarrhythmic drug Therapy
Propafenone, Sotalol and Amiodarone

Device:
• cryoballoon ablation
Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm.

Locations

Country	Name	City	State
China	Affiliated hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Arrhythmia recurrence during blanking period	atrial tachycardia recurrence	3 months
Secondary	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
Secondary	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