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

NCT06200311 | Recruiting

• 1 other identifier: RACE X trial
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrillation, Atrial; Atrial Cardiomyopathy

Keywords

pulmonary vein isolation; mHealth; atrial fibrillation; atrial cardiomyopathy; AF ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• ACMP progression or regression

  through study completion, a median of 2.5 years

• Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)

  through study completion, a median of 2.5 years

• Hospitalisations/urgent visits for heart failure (HF)

  through study completion, a median of 2.5 years

• Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))

  through study completion, a median of 2.5 years

• Cardiovascular death

  through study completion, a median of 2.5 years

Study Arms (2)

AF ablation

EXPERIMENTAL

These patients will undergo Pulmonary vein isolation (PVI) (only)

Procedure: Pulmonary vein isolation

Pharmacological rhythm management

ACTIVE COMPARATOR

These patients will take rate control medication. If this therapy fails, pharmacological rhythm control and AF ablation are 2nd and 3rd line options respectively within this arm,

Drug: Pharmacological rhythm management

Interventions

Pulmonary vein isolation PROCEDURE

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

Also known as: AF ablation

AF ablation

Pharmacological rhythm management DRUG

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

Pharmacological rhythm management

Eligibility Criteria

• Age: 65 Years - 80 Years
• Gender Eligibility Details: 1:1 by stratitification
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, 9715BS, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Michiel Rienstra, Prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel Rienstra, Prof. dr.

CONTACT

+31503616161; m.rienstra@umcg.nl

Nick L van Vreeswijk, Drs.

CONTACT

0624678451; nickvanvreeswijk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: endpoints will be adjudicated by a blinded clinical endpoint committee
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients with ACMP and AF will be randomised to AF ablation and pharmacological rhythm management

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 11, 2024
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 25, 2029
• Study Completion (Estimated): July 25, 2029
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)