Atrial Fibrillation Clinical Trial
Official title:
CopenHeartRFA - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Atrial Fibrillation With Radio Frequency Ablation
Atrial fibrillation is the most common arrhythmia and affect 1-2 % of the population in the
western world. Atrial fibrillation can be treated with a relatively new procedure, called
radiofrequency ablation.
The aim of this study is to explore if patients treated with ablation for atrial
fibrillation, benefit from an integrated rehabilitation programme, that consist of physical
training and psycho-educative consultations with a specialised nurse.
The hypothesis is, that integrated rehabilitation can improve mental health, physical
capacity and other factors.
1-2 % of the population in the western world live with atrial fibrillation. One way to treat
atrial fibrillation is with radiofrequency ablation. Ablation is a relatively new treatment
and therefore only few studies has been exploring how the patients are doing after
discharge. In Denmark the patients are not offered rehabilitation, only brief follow-up with
a doctor. Therefore the aim of this study is to explore if the patients will benefit from a
integrated rehabilitation programme consisting of physical training and psycho-educational
intervention.
A randomized clinical trial is conducted to investigate the effect and meaning of an
integrated rehabilitation programme on the physical and psychosocial functioning of patients
treated for atrial fibrillation with radiofrequency ablation. The trial is a parallel arm
design.
A mixed methods embedded experimental design is chosen to include both quantitative and
qualitative data to evaluate the intervention. The intervention consists of four
psycho-educational consultations provided by specialized nurses and a twelve week
individualized exercise training programme provided by physiotherapists. A qualitative
post-intervention study will explore rehabilitation participation experiences.
The hypothesis is, that integrated rehabilitation can improve mental health, physical
capacity, self-rated health, quality of life, sleep-quality and reduce anxiety, depression,
health care utilisation, work cessation and mortality in patients treated for atrial
fibrillation with radiofrequency ablation and that it is cost effective.
210 patients will be included.
Questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews
will be used to evaluate the effect and meaning of the programme.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
| Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
| Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
| Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
| Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
| Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
| Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
| Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
| Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
| Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
| Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
| Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
| Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
| Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
| Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
| Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |