Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

NCT ID: NCT03573869

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2022-06-01

Brief Summary

In this study 404 patients with heart failure and an ejection fraction of 0.40 or less, with paroxysmal atrial fibrillation, will be randomly assigned to standard treatment or standard treatment plus a session of cryoballoon ablation (left atrial balloon cryoablation for pulmonary vein isolation). All patients with either have an ICD or CRT-D/P device implanted or an implantable electrocardiographic monitoring device. The primary study endpoint will be the time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time).16 This AF burden corresponds to 7.2 hours per month.

A powered secondary endpoint will be the time to the composite of all-cause mortality and unplanned hospitalization for heart failure.

Conditions

Atrial Fibrillation; Heart Failure, Systolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cryoballoon ablation

A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12F FlexCath steerable sheath (Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.

Group Type: EXPERIMENTAL

Cryoballoon ablation

Intervention Type: PROCEDURE

Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Standard treatment

Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cryoballoon ablation

Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
• LVEF <40% on sinus rhythm,
• symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
• age >21 years old.

Exclusion Criteria

• previous left atrial ablation,
• left atrial diameter >28 mm/m2 BSA on TTE (parasternal long axis view),
• strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
• pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
• known primary electrical heart disease (e.g. Brugada syndrome),
• presence of thrombus in a heart chamber,
• presence of prosthetic valve at any position,
• moderate/severe valvular heart disease,
• active infectious disease or malignancy,
• moderate or severe hepatic impairment (Child-Pugh class B or C),
• severe renal failure (estimated glomerular filtration rate <20 ml/min/1.73 m2),
• inability or unwillingness to adhere to standard treatment or to provide consent.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G.Gennimatas General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Spyridon Deftereos

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Athens General Hospital "G. Gennimatas"

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Facility Contacts

Charalampos Kossyvakis, MD, PhD

Role: primary

ckossyvakis@gmail.com

00302107768560

Georgios Giannopoulos, MD,PhD

Role: backup

ggiann@med.uoa.gr

00302107768244

Other Identifiers

39052/21-12-17

Identifier Type: -

Identifier Source: org_study_id