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

January 22, 2024 updated by: University Medical Center Groningen
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AF ablation
These patients will undergo Pulmonary vein isolation (PVI) (only)
Procedure: Pulmonary vein isolation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)
Other Names:
  • AF ablation
Active Comparator: Pharmacological rhythm management
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
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.
Time Frame: through study completion, a median of 2.5 years
Atrial cardiomyopathy (ACMP)-associated complications
through study completion, a median of 2.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACMP progression or regression
Time Frame: through study completion, a median of 2.5 years
As measured by LAVI (left atrial volume index) increase or decrease
through study completion, a median of 2.5 years
Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)
Time Frame: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for AF, AFL or AT
through study completion, a median of 2.5 years
Hospitalisations/urgent visits for heart failure (HF)
Time Frame: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for heart failure
through study completion, a median of 2.5 years
Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))
Time Frame: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for ischemic stroke (including TIA)
through study completion, a median of 2.5 years
Cardiovascular death
Time Frame: through study completion, a median of 2.5 years
Cardiovascular death
through study completion, a median of 2.5 years
All-cause mortality
Time Frame: through study completion, a median of 2.5 years
All-cause mortality
through study completion, a median of 2.5 years
Repeated hospitalisations/urgent visits for ACMP associated outcomes
Time Frame: through study completion, a median of 2.5 years
(AF/AFL/AT recurrence, HF, ischemic stroke admissions)
through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL)
Time Frame: through study completion, a median of 2.5 years
Measured by AFEQT questionnaire
through study completion, a median of 2.5 years
Healthcare costs
Time Frame: through study completion, a median of 2.5 years
Healthcare costs
through study completion, a median of 2.5 years
Transthoracic echo measures
Time Frame: through study completion, a median of 2.5 years
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
Extended ECG measures
Time Frame: through study completion, a median of 2.5 years
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
Biomarkers
Time Frame: through study completion, a median of 2.5 years
Exploratory outcome
through study completion, a median of 2.5 years
Electrophysiological mapping (subset, e.g. low voltage areas)
Time Frame: through study completion, a median of 2.5 years
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
CT (subset, epicardial fat distribution)
Time Frame: through study completion, a median of 2.5 years
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
MRI (subset, fibrosis and fatty infiltration)*
Time Frame: through study completion, a median of 2.5 years
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
AF symptoms
Time Frame: through study completion, a median of 2.5 years
Measured by European Heart Rhythm Association (EHRA)-score
through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL)
Time Frame: through study completion, a median of 2.5 years
Measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)
through study completion, a median of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Michiel Rienstra, Prof. dr., University Medical Center Groningen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACE X trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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