Fibrillation, AtrialRACE XNCT06200311
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
A study testing Pulmonary vein isolation and Pharmacological rhythm management in people with Fibrillation, Atrial and Atrial Cardiomyopathy, run by University Medical Center Groningen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Fibrillation, Atrial, Atrial Cardiomyopathy
- What is being tested?
- Pulmonary vein isolation and Pharmacological rhythm management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Jul 2024to 25 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Fibrillation, Atrial, Atrial Cardiomyopathy
- Being tested
- Pulmonary vein isolation, Pharmacological rhythm management
- Keywords
- pulmonary vein isolation, mHealth, atrial fibrillation, atrial cardiomyopathy, AF ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Also called AF ablation
Pulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA)
Pharmacological rhythm managementDrug
1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation
| Study group | Role | What they receive |
|---|---|---|
| AF ablation | Experimental | These patients will undergo Pulmonary vein isolation (PVI) (only) Receives: 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, Receives: Drug: Pharmacological rhythm management |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.
Atrial cardiomyopathy (ACMP)-associated complications
Measured: through study completion, a median of 2.5 years
Secondary outcomes (8)
ACMP progression or regression
As measured by LAVI (left atrial volume index) increase or decrease
Measured: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)
Hospitalisations/urgent visits for AF, AFL or AT
Measured: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for heart failure (HF)
Hospitalisations/urgent visits for heart failure
Measured: through study completion, a median of 2.5 years
Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))
Hospitalisations/urgent visits for ischemic stroke (including TIA)
Measured: through study completion, a median of 2.5 years
Cardiovascular death
Cardiovascular death
Measured: through study completion, a median of 2.5 years
All-cause mortality
All-cause mortality
Measured: through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)
Measured: through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL) measured by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire (higher score indicating less symptoms and a better QoL)
Measured: through study completion, a median of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start25 Jul 2024
- Primary completion25 Jul 2029 (estimated)
- Study completion25 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients with ACMP and AF will be randomised to AF ablation and pharmacological rhythm management
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel Rienstra, Prof. dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200311
- Sponsor's protocol ID
- RACE X trial
- Acronym
- RACE X
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
- ClinicalTrials.gov ID
- NCT06200311
- Acronym / sponsor ID
- RACE X / RACE X trial
- Conditions
- Fibrillation, Atrial, Atrial Cardiomyopathy
- Keywords
- pulmonary vein isolation, mHealth, atrial fibrillation, atrial cardiomyopathy, AF ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Jul 2029 (estimated)
- Study completion
- 25 Jul 2029 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients with ACMP and AF will be randomised to AF ablation and pharmacological rhythm management
| Arm | Type | Receives |
|---|---|---|
| AF ablation | Experimental | Procedure: Pulmonary vein isolationThese patients will undergo Pulmonary vein isolation (PVI) (only) |
| Pharmacological rhythm management | Active comparator | Drug: Pharmacological rhythm managementThese 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, |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary vein isolationAlso: AF ablationPulmonary vein isolation using pulsed field ablation (PFA), cryoballoon or radiofrequency ablation (RFA) | Procedure or surgery | AF ablation |
| Pharmacological rhythm management1st line: rate control, 2nd line: pharmacological rhythm management. 3rd line: AF ablation | Drug | Pharmacological rhythm management |
Primary outcome
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
8 secondary outcomes
ACMP progression or regression
Time frame: 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 heart failure (HF)
Time frame: 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
Cardiovascular death
Time frame: through study completion, a median of 2.5 years
All-cause mortality
Time frame: through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)
Time frame: through study completion, a median of 2.5 years
Symptoms and improve quality of life (QoL) measured by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire (higher score indicating less symptoms and a better QoL)
Time frame: through study completion, a median of 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michiel Rienstra, Prof. dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation and Pharmacological rhythm management in people with Fibrillation, Atrial and Atrial Cardiomyopathy, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michiel Rienstra, Prof. dr. (+31503616161, m.rienstra@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit. (time frame: through study completion, a median of 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.