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

Primary Purpose

Atrial Fibrillation, Heart Failure, Systolic

Status

Unknown status

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Cryoballoon ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Athens General Hospital "G. Gennimatas"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cryoballoon ablation

Standard treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

All-cause mortality or hospitalization for heart failure

Time to the composite of all-cause mortality and unplanned hospitalization for heart failure

Full Information

NCT ID

NCT03573869

First Posted

June 8, 2018

Last Updated

July 6, 2018

Sponsor

G.Gennimatas General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03573869

Brief Title

Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

Acronym

AFICHE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

G.Gennimatas General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Heart Failure, Systolic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cryoballoon ablation

Arm Type

Experimental

Arm Description

Arm Title

Standard treatment

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Cryoballoon ablation

Intervention Description

Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Primary Outcome Measure Information:

Title

Time to exceed AG burden cut-off of 1%

Description

The time to AF burden exceeding 1% over any 30-day period (calculated as the ratio of time spent in AF over total time)

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

All-cause mortality or hospitalization for heart failure

Description

Time to the composite of all-cause mortality and unplanned hospitalization for heart failure

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Athens General Hospital "G. Gennimatas"

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charalampos Kossyvakis, MD, PhD

Phone

00302107768560

ckossyvakis@gmail.com

First Name & Middle Initial & Last Name & Degree

Georgios Giannopoulos, MD,PhD

Phone

00302107768244

ggiann@med.uoa.gr

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

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