Ablation of Atrial Fibrillation in Heart Failure Patients

Atrial Fibrillation Clinical Trial

— CONTRA-HF  

Official title:

Cryoablation of Atrial Fibrillation in Patients With Severe Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062241
• Other study ID #: CONTRA-HF study
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2017
• Last updated: November 4, 2017
• Start date: January 23, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2017
• Source: Medical University of Silesia
• Contact: Zbigniew Kalarus, MD, Ph.D.
• Phone: 0048322713414
• Email: karzab[@]sum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure
• Severe Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Cardiology, Congenital Heart Diseases and Electrotherapy Medical University of Silesia, Silesian Center of Heart Diseases	Zabrze

Sponsors (4)

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

Country where clinical trial is conducted

Poland, 

References & Publications (9)

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 Electro — View Citation

Khan MN, Jaïs 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, Br — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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):2 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with arrhythmias incidence	the effectiveness of the cryoablation assessed on the device interrogation; atrial fibrillation burden at least 30 seconds	one year
Other	Percentage of patients with arrhythmias incidence	the effectiveness of the cryoablation assessed on the clinical symptoms; the presence of arrhythmias' related symptoms	one year
Other	Quality of life assessment	The Minnesota Living with Heart Failure Questionnaire	one year
Other	Left ventricle ejection fraction assessment	transthoracic echocardiography	one year
Other	Patient capacity assessment	six minute walk test	six months
Other	Oxygen consumption assessment	cardio-pulmonary exercise test	six months
Other	Percentage of patients requiring hospitalization because of arrhythmias' incidence or symptoms (atrial fibrillation/ atrial flutter)	patients who required pharmacological or electrical cardioversion	one year
Other	Percentage of biventricular pacing assessment	the percentage of biventricular pacing assessed on the device interrogation	one year
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of patients who had ischaemic cerebral stroke during 12 months follow up	ischaemic cerebral stroke confirmed in computed tomography	one year