## Protocol Section
### Identification Module
**NCT ID:** NCT06417242

**Acronym:** PrOAF-HF

**Brief Title:** Predicting Outcomes in Atrial Fibrillation and Heart Failure

**Official Title:** Predicting Outcomes in Atrial Fibrillation and Heart Failure

#### Organization Study ID Info
**ID:** 318987
#### Organization
**Class:** OTHER
**Full Name:** Guy's and St Thomas' NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2026-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Guy's and St Thomas' NHS Foundation Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 and/or 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.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

- Heart Failure

**Keywords:**

- ablation

- atrial fibrillation

- AF

- heart failure

- HF

- rhythm control

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with no history of atrial fibrillation at the time of first diagnosis of heart failure

**Label:** HF index disease

#### Arm Group 2

**Description:** Patients in whom the index disease is unknown or in whom atrial fibrillation is the index disease

**Label:** Unclear index disease

### Outcomes Module

#### Primary Outcomes

**Description:** Change in left ventricular ejection fraction measured on echocardiography

**Measure:** Change in LVEF

**Time Frame:** 6 months post ablation

#### Secondary Outcomes

**Description:** Change in left ventricular ejection fraction on echocardiography

**Measure:** Immediate change in LVEF

**Time Frame:** Immediately post procedure

**Description:** Presence of AF

**Measure:** AF recurrence

**Time Frame:** 6 months post ablation

**Description:** Termination of AF during the ablation procedure

**Measure:** Termination of AF during the procedure

**Time Frame:** Intraprocedural

**Description:** Hospitalization for any reason

**Measure:** Hospitalization

**Time Frame:** 6 months

**Description:** Death of any cause and cardiovascular death

**Measure:** Death

**Time Frame:** 6 months

**Description:** Invasive measurements of all four chambers pressure changes during the ablation

**Measure:** Pressure measurements as predictors of change in LVEF

**Time Frame:** Intraprocedural measurements - change in LVEF as above

**Description:** Change in atrial fibrillation burden assessed on a continuous Holter monitor

**Measure:** Change in atrial fibrillation burden

**Time Frame:** 6 months post ablation

**Description:** Change in quality of lide questionnaire scores

**Measure:** Change in symptoms

**Time Frame:** 6 months post ablation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Symptomatic persistent AF
* LVEF ≤40% prior to commencement of treatment
* NYHA class ≥2
* Patient must have been commenced on guideline directed medical therapy (GDMT)
* Patient planning to proceed to radiofrequency atrial fibrillation ablation
* Age 18-80 years
* Able and willing to provide written informed consent

Exclusion Criteria:

* Any clinical contra-indication to ablation
* Any disease limiting life expectancy to \<1 year
* Potential participant currently pregnant or breast feeding
* Contraindication to MRI
* Paroxysmal or permanent AF
* Unable to understand verbal or written explanations given in English

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients with diagnosis of both heart failure and atrial fibrillation, listed for atrial fibrillation ablation will be recruited for the study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** magda.klis@kcl.ac.uk

**Name:** Magdalena Klis, MD

**Phone:** 02071887188

**Phone Ext:** 56308

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-31
