Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

Fibrillation, Atrial Clinical Trial

— RACE X  

Official title:

Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06200311
• Other study ID #: RACE X trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2029

Study information

• Verified date: May 2024
• Source: University Medical Center Groningen
• Contact: Michiel Rienstra, Prof. dr.
• Phone: +31503616161
• Email: m.rienstra[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index >34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.

Description:

The RACE X trial investigates the impact of atrial cardiomyopathy (ACMP) and ablation timing on adverse outcomes in atrial fibrillation (AF) patients. ACMP leads to an atrial substrate less responsive to rhythm control, exacerbating AF recurrence and progression. This trial assesses whether AF ablation versus pharmacological rhythm management reduces the combined primary endpoint of cardiovascular (CV) death and hospitalization in ACMP and AF patients. Secondary objectives include measuring ACMP progression, ACMP-related outcomes, mortality, hospitalizations, AF symptoms, quality of life, and healthcare costs. Exploratory goals involve various additional measurements. This prospective, multicenter, open-label, blinded-endpoint, phase IIIb trial randomizes patients with ACMP and AF to receive either AF ablation or pharmacological rhythm management. Follow-up involves mobile health (mHealth) applications, questionnaires, and heart rhythm monitoring across 13 Dutch hospitals. Ineligible patients undergoing AF ablation join an observational registry. The trial population consists of patients aged 65-80 years with confirmed ACMP and ECG-confirmed AF. With 604 patients and a median 2.5-year follow-up, the trial aims to assign patients equally to each intervention. The primary endpoint is a composite of CV death and hospitalization. Catheter ablation, a safe and efficient technique, minimizes patient burden, and remote follow-up through mHealth reduces site visits. Additional study procedures are integrated into routine care, ensuring a streamlined process.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 604
• Est. completion date: July 2029
• Est. primary completion date: July 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion criteria

• Confirmed ACMP (LAVI >34 ml/m2)

• ECG-confirmed AF

• Age: 65-80 years old

• Patients eligible for both treatment strategies judged by the treating physician signed and dated informed consent prior to admission to the trial

Exclusion criteria

• Longstanding (>1 year) persistent or permanent (accepted) AF

• Previous left atrial (LA) ablation or LA surgery

• AF due to a reversible cause (e.g. hyperthyroidism, post-operative AF)

• Recent (<90 days) acute coronary syndrome, stroke/TIA or cardiac intervention (Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical))

• Intracardiac thrombus

• HF NYHA III/IV

• Impaired renal function, defined as estimated glomerular filtration rate =25 ml/min/1.73m2

• Presence of (or scheduled for) mechanical assist device or heart transplant

• Severe aortic or mitral valve disease

• Complex congenital heart disease

• Life expectancy <1 year

• Currently enrolled in another clinical randomized trial

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiomyopathies
• Disease Progression
• Fibrillation, Atrial

Intervention

Procedure:
• Pulmonary vein isolation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)

Drug:
• Pharmacological rhythm management
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.	Atrial cardiomyopathy (ACMP)-associated complications	through study completion, a median of 2.5 years
Secondary	ACMP progression or regression	As measured by LAVI (left atrial volume index) increase or decrease	through study completion, a median of 2.5 years
Secondary	Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)	Hospitalisations/urgent visits for AF, AFL or AT	through study completion, a median of 2.5 years
Secondary	Hospitalisations/urgent visits for heart failure (HF)	Hospitalisations/urgent visits for heart failure	through study completion, a median of 2.5 years
Secondary	Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))	Hospitalisations/urgent visits for ischemic stroke (including TIA)	through study completion, a median of 2.5 years
Secondary	Cardiovascular death	Cardiovascular death	through study completion, a median of 2.5 years
Secondary	All-cause mortality	All-cause mortality	through study completion, a median of 2.5 years
Secondary	Repeated hospitalisations/urgent visits for ACMP associated outcomes	(AF/AFL/AT recurrence, HF, ischemic stroke admissions)	through study completion, a median of 2.5 years
Secondary	AF symptoms	Measured by European Heart Rhythm Association (EHRA)-score	through study completion, a median of 2.5 years
Secondary	Symptoms and improve quality of life (QoL)	Measured by AFEQT questionnaire	through study completion, a median of 2.5 years
Secondary	Symptoms and improve quality of life (QoL)	Measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)	through study completion, a median of 2.5 years
Secondary	Healthcare costs	Healthcare costs	through study completion, a median of 2.5 years
Secondary	Transthoracic echo measures	This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. strain measures, LAVI etc)	through study completion, a median of 2.5 years
Secondary	Extended ECG measures	This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. p wave duration voltage or surface etc)	through study completion, a median of 2.5 years
Secondary	Biomarkers	Exploratory outcome	through study completion, a median of 2.5 years
Secondary	Electrophysiological mapping (subset, e.g. low voltage areas)	This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. low voltage areas, potential fragmentation etc)	through study completion, a median of 2.5 years
Secondary	CT (subset, epicardial fat distribution)	This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. epicardial fat distribution)	through study completion, a median of 2.5 years
Secondary	MRI (subset, fibrosis and fatty infiltration)*	This is a exploratory outcome and will be defined during the trial by input of the other workpackages of the EmbRACE consortium (i.e. fibrosis and fatty infiltration)	through study completion, a median of 2.5 years