Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417242
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-13
Brief Title:
Predicting Outcomes in Atrial Fibrillation and Heart Failure
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Predicting Outcomes in Atrial Fibrillation and Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrOAF-HF
Brief Summary:
PrOAF-HF will aim to test if rhythm control delivered through catheter ablation in patients in whom it is not clear whether atrial fibrillation or heart failure were the first disease results in a greater improvement in left ventricular ejection fraction LVEF compared with patients where heart failure was diagnosed first with no evidence of AF
Detailed Description:
Heart failure is a chronic disease affecting half a million patients in the UK Up to 40 of patients with heart failure also suffer from atrial fibrillation A subgroup of patients with atrial fibrillation and heart failure have tachycardia induced cardiomyopathy and benefit from significant improvement of the left ventricular function with restoration of sinus rhythm Currently those patients can only be identified based on their response to treatment Investigators aim to improve the treatment of AF-HF patients The group will develop a robust modelling framework for simulating the hearts of AF-HF patients hearts to predict patients response to therapy and infer patient history This modelling framework will enable integration of predictive simulations into clinical study design where the inferred initiating disease and predicted patient response to therapy are tested for selecting either rate or rhythm control in AF-HF patients
The primary objective is to test if rhythm control delivered through catheter ablation in patients where either the index disease is unclear or where AF was diagnosed prior to the onset of HF improves LVEF more than in patients where HF was diagnosed first with no evidence of AF
The secondary objectives are to examine whether the ability to terminate AF during pulmonary vein isolation is influenced by the identified index disease and to determine whether the identified index disease affects AF recurrence rate at 6 months andor burden post ablation This study will also identify whether the index disease affects pressure measurements as predictors of change in ejection fraction hospitalisation and death rates during the follow up period
This will be a non-interventional cohort study Routinely acquired clinical data collected during pre-procedure work up will be accessed for research purposes including 24-48 hour ambulatory Holter monitoring electrocardiograph ECG in AF and in sinus rhythm if available echocardiography and clinical history and examination details
Additionally an atrial cardiac magnetic resonance imaging MRI scan will be performed including assessment of atrial structure function fibrosis and epicardial fat burden Symptom questionnaires will be performed During the ablation procedure additional time will be taken to perform electrophysiological assessment in all four chambers of the heart
The primary objective is to test if rhythm control delivered through catheter ablation in patients where either the index disease is unclear or where AF was diagnosed prior to the onset of HF improves LVEF more than in patients where HF was diagnosed first with no evidence of AF
The secondary objectives are to examine whether the ability to terminate AF during pulmonary vein isolation is influenced by the identified index disease and to determine whether the identified index disease affects AF recurrence rate at 6 months andor burden post ablation This study will also identify whether the index disease affects pressure measurements as predictors of change in ejection fraction hospitalisation and death rates during the follow up period
This will be a non-interventional cohort study Routinely acquired clinical data collected during pre-procedure work up will be accessed for research purposes including 24-48 hour ambulatory Holter monitoring electrocardiograph ECG in AF and in sinus rhythm if available echocardiography and clinical history and examination details
Additionally an atrial cardiac magnetic resonance imaging MRI scan will be performed including assessment of atrial structure function fibrosis and epicardial fat burden Symptom questionnaires will be performed During the ablation procedure additional time will be taken to perform electrophysiological assessment in all four chambers of the heart
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None