Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

NCT03573869 | Unknown DMC

• 1 other identifier: 39052/21-12-17
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• All-cause mortality or hospitalization for heart failure

  Up to 2 years

Study Arms (2)

Cryoballoon ablation

EXPERIMENTAL

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

Standard treatment

NO INTERVENTION

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

Interventions

Cryoballoon ablation PROCEDURE

Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Cryoballoon ablation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead

Study Sites (1)

Athens General Hospital "G. Gennimatas"

Athens, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 29, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: July 9, 2018

Record last verified: 2018-07

Locations

GR (1)