Quality of life before and after atrial fibrillation ablation

ISRCTN	ISRCTN92142233
DOI	https://doi.org/10.1186/ISRCTN92142233

Submission date: 23/02/2022
Registration date: 28/02/2022
Last edited: 28/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Atrial fibrillation (AF) is a heart condition that causes an irregular and often abnormally fast heart rate. Ablation of AF is an alternative to drug treatment. Ablation is where the area inside the heart that's causing the abnormal heart rhythm is destroyed using radiofrequency energy. Gender differences in symptoms and perceived health-related quality of life (HRQOL) in patients with AF have been reported previously. Women experience a lower HRQOL, faster heart rate, and more symptoms such as palpitations (heart pounding or racing) and dyspnea (breathing difficulties) than men. Furthermore, they experience worse physical functioning independently of other heart diseases or age. Despite more symptoms, women are less often referred for cardioversion and ablation of atrial fibrillation. The aim of this study is to evaluate symptoms, morbidity (illness), referral patterns, experience of the information given, functional impairment, HRQOL, and perceived improvement from a gender perspective in patients with AF before and 6 months after ablation.

Who can participate?
Patients aged over 18 years referred for atrial fibrillation ablation

What does the study involve?
Questionnaires and data from the patient’s file are used to investigate quality of life, symptoms and referral experiences before AF ablation and 6 months after ablation.

What are the possible benefits and risks of participating?
There are benefits or risks for the participant.

Where is the study run from?
Karolinska Hospital (Sweden)

When is the study starting and how long is it expected to run for?
January 2011 to July 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Carina Carnlöf
carina.carnlof@regionstockholm.se

Contact information

Mrs Carina Carnlöf
Principal Investigator

Karolinska University Hospital
Heart, Vascular & Neurology Theme
M97
Stockholm
14186
Sweden

ORCID ID	0000-0001-5964-0393
Phone	+46 (0)70 626 15 98
Email	carina.carnlof@regionstockholm.se

Study information

Study design	Single-center cohort study with a prospective design
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request participants information sheet
Scientific title	Women with atrial fibrillation improve more than men at 6 months follow-up after pulmonary vein isolation
Study objectives	This study evaluates referral patterns and symptoms, morbidity, functional impairment, and health-related quality of life (HRQOL) from a gender perspective in patients with atrial fibrillation (AF) before and 6 months after pulmonary vein isolation (PVI).
Ethics approval(s)	Approved 28/02/2012, Regional Institutional Ethics Committee (Regionala Etikprövningsmyndigheten, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; +46 (0)8 524 8000; registrator@etikprovningen.se), ref: 2011/1903-31/2
Health condition(s) or problem(s) studied	Atrial fibrillation
Intervention	The study is a single-center cohort study with a prospective design using different questionnaires at baseline to investigate quality of life (QoL), symptoms and referral experiences before atrial fibrillation ablation with a follow-up of QoL and symptoms at 6 months post ablation.
Intervention type	Other
Primary outcome measure	1. Symptoms measured using the Symptom Checklist-Frequency and Severity Scale (SCL) at baseline and 6 months 2. QoL measured using the Short Form-36 (SF-36) health survey questionnaire at baseline and 6 months 3. Functional impairment measured using the Sick Impact Profile at baseline and 6 months
Secondary outcome measures	Referral history, experience of information given in regard to the arrhythmia, number of years with symptomatic atrial fibrillation (AF), and previous evaluations and diagnoses of their arrhythmia symptoms, measured with a supplementary questionnaire at baseline
Overall study start date	01/01/2011
Completion date	12/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	240
Total final enrolment	240
Key inclusion criteria	Patients referred for a de novo PVI
Key exclusion criteria	1. Inability to read or understand Swedish 2. Cognitive impairment
Date of first enrolment	21/02/2013
Date of final enrolment	12/01/2016

Locations

Countries of recruitment

Sweden

Study participating centre

Karolinska University Hospital

Heart, Vascular & Neurology Theme
M97
Stockholm
141 86
Sweden

Sponsor information

Karolinska Institute
University/education

Hälsovägen
Stockholm
141 86
Sweden

Phone	+46 (0)8 585 800 00
Email	mats.jensen-urstad@ki.se
Website	http://ki.se/en/startpage
"ROR"	https://ror.org/056d84691

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/04/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. Additional files will be available upon request. The protocol and participant information sheet are written in Swedish.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Carina Carnlöf (carina.carnlof@regionstockholm.se). All patients gave their written consent, and all data are logged in a dataset in SPSS. The dataset is anonymised with a study number.

Editorial Notes

28/02/2022: Trial's existence confirmed by the Regional Institutional Ethics Committee.