NCT03062241

Brief Summary

The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations, mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

February 9, 2017

Last Update Submit

November 4, 2017

Conditions

Atrial FibrillationSevere Heart Failure

Keywords

cryoablationconventional treatment of heart failure

Outcome Measures

Primary Outcomes (4)

  • Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.

    percentage of patients who required intravenous diuretic or pressor administration

    one year

  • Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.

    percentage of patients who died

    one year

  • Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.

    percentage of patients who required mechanical left ventricle support

    one year

  • Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.

    percentage of patients who had a heart transplant

    one year

Secondary Outcomes (1)

  • Percentage of patients who had ischaemic cerebral stroke during 12 months follow up

    one year

Other Outcomes (8)

  • Percentage of patients with arrhythmias incidence

    one year

  • Percentage of patients with arrhythmias incidence

    one year

  • Quality of life assessment

    one year

  • +5 more other outcomes

Study Arms (2)

Cryoablation

EXPERIMENTAL

The pulmonary vein (PV) isolation in patients randomized to intervention group.

Procedure: Cryoablation

Conventional treatment

NO INTERVENTION

Pharmacological treatment according to 2016 ESC (European Society of Cardiology) guidelines for the diagnosis and treatment of acute and chronic heart failure and to 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with European Association for Cardio-Thoracic Surgery (EACTS).

Interventions

CryoablationPROCEDURE

After left atrial appendage (LAA) thrombus exclusion, the transseptal puncture will be performed and intravenous heparin will be administered to achieve Activated Clotting Time (ACT) ≥300 seconds.The pulmonary vein (PV) isolation will be performed. Optimal cryoballoon positioning will be confirmed by PVs angiography. Pulmonary veins isolation will be confirmed by entrance/exit block using appropriate catheter. During cryoablation of the right PVs, high-output right phrenic nerve stimulation will be performed using a diagnostic catheter placed in the superior vena cava. Whenever decrease/loss of pacing capture will be observed, cryoablation will be immediately terminated.

Cryoablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years ≤ age ≤ 75 years
  • optimal pharmacotherapy within the last 3 months
  • New York Heart Association (NYHA) II- IV (out-patient) within the last 3 months
  • AF paroxysmal, persistent or persistant long-lasting
  • at least 1 episode of paroxysmal AF with the duration of ≥ 30 s or AF burden ≥ 10% during 1 month up to 1 year since ICD or CRT-D implantation
  • signed informed consent

You may not qualify if:

  • age \< 18 years or \> 75 years
  • permanent AF
  • contraindications to oral anticoagulation or heparin
  • prior AF ablation
  • chronic kidney disease requiring dialysis
  • untreated hypo- or hyperthyroidism
  • breast feeding
  • pregnancy
  • decompensated heart failure within the last 90 days requiring pressor infusion
  • stroke within the last 3 months
  • myocardial infarction within the last 3 months
  • PCI or CABG within the last 3 months
  • active myocarditis
  • artificial valve replacement surgery
  • severe mitral or aortic stenosis
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases

Zabrze, 41-800, Poland

RECRUITING

Related Publications (9)

  • Xiong Q, Proietti M, Senoo K, Lip GY. Asymptomatic versus symptomatic atrial fibrillation: A systematic review of age/gender differences and cardiovascular outcomes. Int J Cardiol. 2015 Jul 15;191:172-7. doi: 10.1016/j.ijcard.2015.05.011. Epub 2015 May 7.

    PMID: 25974193BACKGROUND

  • Vaidya K, Arnott C, Russell A, Masson P, Sy RW, Patel S. Pulmonary Vein Isolation Compared to Rate Control in Patients with Atrial Fibrillation: A Systematic Review and Meta-analysis. Heart Lung Circ. 2015 Aug;24(8):744-52. doi: 10.1016/j.hlc.2015.02.025. Epub 2015 Mar 14.

    PMID: 25890871BACKGROUND

  • Lenarczyk R, Jedrzejczyk-Patej E, Szulik M, Mazurek M, Podolecki T, Kowalczyk J, Kowalski O, Sredniawa B, Kalarus Z; Triple-Site Versus Standard Cardiac Resynchronization Trial (TRUST CRT) Investigators. Atrial fibrillation in cardiac resynchronization recipients with and without prior arrhythmic history. How much of arrhythmia is too much? Cardiol J. 2015;22(3):267-75. doi: 10.5603/CJ.a2014.0102. Epub 2015 Jan 7.

    PMID: 25563708BACKGROUND

  • Marrouche NF, Brachmann J; CASTLE-AF Steering Committee. Catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation (CASTLE-AF) - study design. Pacing Clin Electrophysiol. 2009 Aug;32(8):987-94. doi: 10.1111/j.1540-8159.2009.02428.x.

    PMID: 19659616BACKGROUND

  • Khan MN, Jais P, Cummings J, Di Biase L, Sanders P, Martin DO, Kautzner J, Hao S, Themistoclakis S, Fanelli R, Potenza D, Massaro R, Wazni O, Schweikert R, Saliba W, Wang P, Al-Ahmad A, Beheiry S, Santarelli P, Starling RC, Dello Russo A, Pelargonio G, Brachmann J, Schibgilla V, Bonso A, Casella M, Raviele A, Haissaguerre M, Natale A; PABA-CHF Investigators. Pulmonary-vein isolation for atrial fibrillation in patients with heart failure. N Engl J Med. 2008 Oct 23;359(17):1778-85. doi: 10.1056/NEJMoa0708234.

    PMID: 18946063RESULT

  • Zhao L, Xu K, Jiang W, Zhou L, Wang Y, Zhang X, Wu S, Liu X. Long-term outcomes of catheter ablation of atrial fibrillation in dilated cardiomyopathy. Int J Cardiol. 2015;190:227-32. doi: 10.1016/j.ijcard.2015.04.186. Epub 2015 Apr 23.

    PMID: 25920033RESULT

  • Bunch TJ, May HT, Bair TL, Jacobs V, Crandall BG, Cutler M, Weiss JP, Mallender C, Osborn JS, Anderson JL, Day JD. Five-year outcomes of catheter ablation in patients with atrial fibrillation and left ventricular systolic dysfunction. J Cardiovasc Electrophysiol. 2015 Apr;26(4):363-370. doi: 10.1111/jce.12602. Epub 2015 Feb 11.

    PMID: 25534572RESULT

  • Rillig A, Makimoto H, Wegner J, Lin T, Heeger C, Lemes C, Fink T, Metzner A, Wissner E, Mathew S, Wohlmuth P, Kuck KH, Tilz RR, Ouyang F. Six-Year Clinical Outcomes After Catheter Ablation of Atrial Fibrillation in Patients With Impaired Left Ventricular Function. J Cardiovasc Electrophysiol. 2015 Nov;26(11):1169-1179. doi: 10.1111/jce.12765. Epub 2015 Sep 3.

    PMID: 26217925RESULT

  • Schwartzman D, Housel D, Bazaz R, Jain S, Saba S, Gorcsan J 3rd, Adelstein E. A pilot study to assess benefit of atrial rhythm control after cardiac resynchronization therapy and atrioventricular node ablation. Pacing Clin Electrophysiol. 2015 Feb;38(2):275-81. doi: 10.1111/pace.12535. Epub 2014 Nov 27.

    PMID: 25431023RESULT

MeSH Terms

Conditions

Atrial FibrillationHeart Failure

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Zbigniew Kalarus, MD, Ph.D.

    Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zbigniew Kalarus, MD, Ph.D.

CONTACT

0048322713414karzab@sum.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Randomized Controlled Trial (RCT), non-blinded, prospective, multicentre performed in up to 4 cardiology centers in Poland. All patients implanted with a dual-chamber implanted cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) with Home Monitoring capabilities and history of paroxysmal, persistent or persistant long-lasting AF will be screened for the study. In patient who fulfill all inclusion and none of the exclusion criteria 1 year after ICD or CRT-D implantation, with exclusion of 1 month directly after implantation, a device check-up and AF burden will be performer and assessed. Randomization will be performed using sealed envelopes and will be conducted in the coordinating center of the study PI in all patients who sign informed consent and met all inclusions and none of the exclusion criteria. The cryoablation of AF will be performed within 1 month from randomization in the invasive treatment group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Department

Study Record Dates

First Submitted

February 9, 2017

First Posted

February 23, 2017

Study Start

January 23, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2019

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)