Ablation of Atrial Fibrillation in Heart Failure Patients

Status Recruiting

Clinical Trial 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..

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03062241
Study type	Interventional
Source	Medical University of Silesia
Contact	Zbigniew Kalarus, MD, Ph.D.
Phone	0048322713414
Email	karzab@sum.edu.pl
Status	Recruiting
Phase	N/A
Start date	January 23, 2017
Completion date	July 31, 2019

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ablation of Atrial Fibrillation in Heart Failure Patients — CONTRA-HF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms