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Atrial FIbrillation Treatment With Cryoballoon in Heart failurE (AFICHE)

NCT03573869 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2018-07-09

No results posted yet for this study

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

Interventions

PROCEDURE

Cryoballoon ablation

Left atrial ablation using cryoballoon to achieve pulmonary vein isolation

Sponsors & Collaborators

  • G.Gennimatas General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-12-31
Completion
2022-06-01

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573869 on ClinicalTrials.gov