Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE) (AFICHE)

Effect of Cryoballoon Pulmonary Vein Isolation on Atrial Fibrillation Burden and Clinical Endpoints in Patients With Heart Failure With Impaired Left Ventricular Systolic Function

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Heart Failure, Systolic
• Intervention / Treatment: Procedure: Cryoballoon ablation

• Study Type: Interventional
• Enrollment (Anticipated): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Athens General Hospital "G. Gennimatas"
    • Contact: Charalampos Kossyvakis, MD, PhD; Phone Number: 00302107768560; Email: ckossyvakis@gmail.com
    • Contact: Georgios Giannopoulos, MD,PhD; Phone Number: 00302107768244; Email: ggiann@med.uoa.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Cryoballoon ablation; Left atrial ablation using cryoballoon to achieve pulmonary vein isolation
No Intervention: Standard treatment; Standard treatment, including at least one rhythm control medication, on top of optimized rate control and HF treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to exceed AG burden cut-off of 1%	The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality or hospitalization for heart failure	Time to the composite of all-cause mortality and unplanned hospitalization for heart failure	Up to 2 years

Collaborators and Investigators

• Sponsor: G.Gennimatas General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Murmurs; Heart Failure; Atrial Fibrillation; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: 39052/21-12-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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