Predicting Outcomes in Atrial Fibrillation and Heart Failure

NCT06417242 | Not Yet Recruiting

• 1 other identifier: 318987
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation; Heart Failure

Keywords

ablation; atrial fibrillation; AF; heart failure; HF; rhythm control

Outcome Measures

Primary Outcomes (1)

• Change in LVEF

  Change in left ventricular ejection fraction measured on echocardiography

  6 months post ablation

Secondary Outcomes (8)

• Immediate change in LVEF

  Immediately post procedure

• AF recurrence

  6 months post ablation

• Termination of AF during the procedure

  Intraprocedural

• Hospitalization

  6 months

• Death

  6 months

Study Arms (2)

HF index disease

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

Unclear index disease

Patients in whom the index disease is unknown or in whom atrial fibrillation is the index disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Magdalena Klis, MD

CONTACT

02071887188; magda.klis@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 20, 2024

Record last verified: 2024-05