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

NCT05364866 | Unknown

• 1 other identifier: 2022-K039-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Arrhythmia recurrence during blanking period

  3 months

• Quality of life changes at 12 months measured by 12-Item Short Form Survey (SF-12)

  one year

• Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)

  one year

Study Arms (2)

Medical treatment group

Using class I or class III AAD to maintain sinus rhythm

Drug: Antiarrhythmic drug Therapy

Cryoballoon ablation group

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

Device: cryoballoon ablation

Interventions

Antiarrhythmic drug Therapy DRUG

Propafenone, Sotalol and Amiodarone

Also known as: Class I or III antiarrhythmic drug

Medical treatment group

cryoballoon ablation DEVICE

Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters including 23mm and 28mm.

Cryoballoon ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Anti-Arrhythmia Agents

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Qi Lu, MD

CONTACT

+8613962989292; luqint@sina.com

Haixia Xu, MD

CONTACT

+8615050641838; ntxhx2005@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 6, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)