Ablation of Atrial Fibrillation in Heart Failure Patients (CONTRA-HF)

November 4, 2017 updated by: Zbigniew Kalarus, Medical University of Silesia

Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure

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..

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation (AF) is one of the most common arrhythmia worldwide and the risk of AF incidence increases with age. The amount of patients suffered from AF is still underestimated due to insufficient diagnosing silent AF. The incidence of patients with silent, asymptomatic AF might be approx. 80% , particularly in patients with heart failure. The most frequent consequence of undiagnosed AF is not only thromboembolism but also heart failure development and loss of quality of life. The incidence of chronic heart failure (CHF), which is the most frequent consequence of coronary heart disease, still increases and nowadays in patients above 70 years affects approx.10%. What is more, AF which is one of the result of CHF occurred in 30% of those patients. Atrial fibrillation ablation is one of the most established method to treat symptomatic patients and its' efficacy is about 70 - 90 %. Hence, the appropriate and effective treatment of those patients might influence not only on the survival but also the quality of life and functionality of health care system.

Among many data about AF in patients with impaired LV (left ventricle) systolic function there is still a lack of randomized, multicenter trials which would compare the influence of AF cryoablation with conventional treatment in patients with LVEF (left ventricle ejection fraction) ≤ 35% (despite optimal pharmacotherapy) on long term survival and efficacy. The deficiency in this field was an inspiration to conduct this study.

Study Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Recruiting
        • Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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
  • coronary artery disease requiring revascularization
  • heart transplant
  • participation in another study
  • comorbidities with expected survival less than 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryoablation
The pulmonary vein (PV) isolation in patients randomized to intervention group.
Procedure: Cryoablation
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.
No Intervention: Conventional treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of hospitalization due to heart failure worsening, mortality, use of mechanical left ventricle support and heart transplant.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
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.
Time Frame: one year
percentage of patients who had a heart transplant
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who had ischaemic cerebral stroke during 12 months follow up
Time Frame: one year
ischaemic cerebral stroke confirmed in computed tomography
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with arrhythmias incidence
Time Frame: one year
the effectiveness of the cryoablation assessed on the device interrogation; atrial fibrillation burden at least 30 seconds
one year
Percentage of patients with arrhythmias incidence
Time Frame: one year
the effectiveness of the cryoablation assessed on the clinical symptoms; the presence of arrhythmias' related symptoms
one year
Quality of life assessment
Time Frame: one year
The Minnesota Living with Heart Failure Questionnaire
one year
Left ventricle ejection fraction assessment
Time Frame: one year
transthoracic echocardiography
one year
Patient capacity assessment
Time Frame: six months
six minute walk test
six months
Oxygen consumption assessment
Time Frame: six months
cardio-pulmonary exercise test
six months
Percentage of patients requiring hospitalization because of arrhythmias' incidence or symptoms (atrial fibrillation/ atrial flutter)
Time Frame: one year
patients who required pharmacological or electrical cardioversion
one year
Percentage of biventricular pacing assessment
Time Frame: one year
the percentage of biventricular pacing assessed on the device interrogation
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Military Institute of Medicine, Poland
Clinical Hospital No. 2 Pomeranian Medical University, Szczecin, Poland
Hospital name Pope John Paul, Zamosc, Poland

Investigators

  • Principal Investigator: Zbigniew Kalarus, MD, Ph.D., Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2017

Primary Completion (Anticipated)

July 31, 2018

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 4, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONTRA-HF study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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