Atrial FibrillationRACE-8-HFNCT04342832
Cryoballoon Ablation Versus Medical Therapy in Patients With Heart Failure and Atrial Fibrillation
A study testing Cryoballoon ablation in people with Atrial Fibrillation and Heart Failure, run by Maastricht University at 2 sites in Netherlands.
Trial summary
Rationale: Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Cryoballoon ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Jul 2020to 19 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80;
- HF with ejection fraction <40%, as assessed by recent (<6 months) echocardiography or cardiovascular magnetic resonance imaging (CMR);
- AF, documented on standard ECG or Holter monitoring;
- Eligible for both treatment arms;
- Signed and dated informed consent prior to admission to the trial.
Who cannot join
- End-stage heart failure: NYHA class IV, patients on waiting list for cardiac transplant and/or left ventricular assist device;
- Long-standing (> 1 year) persistent or permanent AF;
- Previous pulmonary vein isolation or surgical ablation;
- Left atrial diameter ≥60 mm or left atrial volume index ≥50 ml/m2;
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) ≤25 ml/min/1.73m2;
- Recent (<90 days) acute coronary syndrome, cardiac intervention1, or stroke/transient ischemic attack (TIA);
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- Planned or expected cardiac surgery in the following year;
- Active infectious disease or malignancy;
- Women who are pregnant or planning to become pregnant during the trial;
- Contraindication for cryoballoon ablation or other condition that may prevent subjects from adhering to the trial protocol, in the opinion of the investigator.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Maastricht UMC+
Maastricht, Limburg, 6229 HX
Radboudumc
Nijmegen, Gelderland, 6525 GA
About this study
Official title: CRyoballoon Ablation Versus mediCal thErapy in Patients With Heart Failure and Atrial Fibrillation: A Multicenter Randomized Clinical Trial, the RACE-8-HF Trial
Rationale:
Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality. Studies in HF patients in which the AF burden is reduced by AF ablation show promising results toward improved prognosis, but so far only one randomized trial is conducted that focused on major clinical endpoints. As the selected patients in this trial were not representative for the entire population and its ablation method varied from patient to patient, it is the aim of the present study to confirm that early invasive therapy consisting of a strict pulmonary vein isolation (PVI) protocol using cryoballoon therapy has positive effects on hard clinical endpoints in a wider variety of patients in the HF population.
Read more
Furthermore, there are no studies which compare cost-effectiveness of an early invasive strategy in this patient category. The investigators expect that avoided hospitalizations and healthcare resource utilizations lead to lower costs in the AF ablation group, despite initial higher costs of the procedure.
Objective:
To compare outcome and cost-effectiveness of early AF ablation by PVI using cryoballoon therapy with standard (medical) therapy in patients with heart failure with reduced ejection fraction.
Study design:
Multicenter, randomized, open label clinical trial.
Study population:
Symptomatic adult patients with heart failure with reduced ejection fraction (<40%) and paroxysmal or persistent AF.
Intervention:
AF ablation (PVI) using cryoballoon therapy.
Outcome measures:
The primary endpoint is a combined endpoint of all-cause mortality, unplanned cardiovascular hospitalization, and stroke (time-to-event analysis).
Secondary endpoints of the trial are:
- A combined endpoint of mortality, number of unplanned cardiovascular hospitalizations, and stroke (recurrent-event analysis);
- A hierarchical endpoint of mortality, unplanned cardiovascular hospitalizations, stroke, and HF complaints;
- Cost-effectiveness. Key exploratory endpoints include individual components of the combined endpoints, days alive out of the hospital, hospitalizations for heart failure, recurrence of atrial arrhythmia, and quality of life.
- Conditions
- Atrial Fibrillation, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic
- Being tested
- Cryoballoon ablation
- Keywords
- Pulmonary vein isolation, Cryoballoon ablation, Atrial fibrillation, Heart failure
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationProcedure or surgery
Also called Pulmonary vein isolation, PVI, CBA
If a patient is randomized to early invasive treatment, the ablation is performed within 3 months by an experienced cardiac electrophysiologist using CE-certified equipment. Via the femoral vein a guiding catheter is advanced through the inferior vena cava to the right atrium and into the left atrium via transseptal puncture. Then, the cryoballoon is advanced, inflated, and placed against one of the four PVs. PV occlusion is assessed by selective contrast injection. When adequate PV antral seal is confirmed, ablation of the tissue in contact with the balloon is performed using pressurized liquid nitrous oxide. The cold inflated balloon thus creates circular lesions around the PV. The balloon and tissue interface are then allowed to reach normal temperatures. Depending on local practice, the freeze-thaw cycle may be repeated twice. Electrical isolation is assessed and when it is confirmed, the next PV is treated in the same way. The procedure ends when all PV's are isolated.
| Study group | Role | What they receive |
|---|---|---|
| Early invasive treatment (cryoballoon ablation) | Active comparator | Not described Receives: Procedure: Cryoballoon ablation |
| Standard medical care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality, unplanned cardiovascular hospitalizations and stroke (time-to-event analysis)
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Secondary outcomes (5)
Combined endpoint of all-cause mortality
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Total number of unplanned cardiovascular hospitalizations and stroke (recurrent-event analysis)
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Hierarchal endpoint of all-cause mortality, unplanned cardiovascular hospitalizations, stroke and change in heart failure complaints (hierarchical endpoint analysis)
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Cost-effectiveness
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Budget impact
Measured: Study duration (1-5 years, expected median follow-up duration 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start16 Jul 2020
- Primary completion19 Apr 2025
- Study completion19 Apr 2025
Why it stopped: Insufficient enrollment speed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Multicenter randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Vernooy, MD PhD, Study chair, Maastricht UMC+, RadboudumcMichiel Rienstra, MD PhD, Study chair, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342832
- Sponsor's protocol ID
- NL71710.068.19
- Acronym
- RACE-8-HF
- Status last verified
- Jul 2025
- First submitted
- 26 Mar 2020
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRyoballoon Ablation Versus mediCal thErapy in Patients With Heart Failure and Atrial Fibrillation: A Multicenter Randomized Clinical Trial, the RACE-8-HF Trial
- ClinicalTrials.gov ID
- NCT04342832
- Acronym / sponsor ID
- RACE-8-HF / NL71710.068.19
- Conditions
- Atrial Fibrillation, Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic
- Keywords
- Pulmonary vein isolation, Cryoballoon ablation, Atrial fibrillation, Heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment speed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 13 Apr 2020 (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.
Rationale:
Atrial fibrillation (AF) and heart failure (HF) can cause each other and sustain each other. Combined, the two diseases negatively influence each other's prognosis and lead to higher mortality. Studies in HF patients in which the AF burden is reduced by AF ablation show promising results toward improved prognosis, but so far only one randomized trial is conducted that focused on major clinical endpoints. As the selected patients in this trial were not representative for the entire population and its ablation method varied from patient to patient, it is the aim of the present study to confirm that early invasive therapy consisting of a strict pulmonary vein isolation (PVI) protocol using cryoballoon therapy has positive effects on hard clinical endpoints in a wider variety of patients in the HF population.
Furthermore, there are no studies which compare cost-effectiveness of an early invasive strategy in this patient category. The investigators expect that avoided hospitalizations and healthcare resource utilizations lead to lower costs in the AF ablation group, despite initial higher costs of the procedure.
Objective:
To compare outcome and cost-effectiveness of early AF ablation by PVI using cryoballoon therapy with standard (medical) therapy in patients with heart failure with reduced ejection fraction.
Study design:
Multicenter, randomized, open label clinical trial.
Study population:
Symptomatic adult patients with heart failure with reduced ejection fraction (<40%) and paroxysmal or persistent AF.
Intervention:
AF ablation (PVI) using cryoballoon therapy.
Outcome measures:
The primary endpoint is a combined endpoint of all-cause mortality, unplanned cardiovascular hospitalization, and stroke (time-to-event analysis).
Secondary endpoints of the trial are:
- A combined endpoint of mortality, number of unplanned cardiovascular hospitalizations, and stroke (recurrent-event analysis);
- A hierarchical endpoint of mortality, unplanned cardiovascular hospitalizations, stroke, and HF complaints;
- Cost-effectiveness. Key exploratory endpoints include individual components of the combined endpoints, days alive out of the hospital, hospitalizations for heart failure, recurrence of atrial arrhythmia, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Early invasive treatment (cryoballoon ablation) | Active comparator | Procedure: Cryoballoon ablation |
| Standard medical care | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18-80;
- HF with ejection fraction <40%, as assessed by recent (<6 months) echocardiography or cardiovascular magnetic resonance imaging (CMR);
- AF, documented on standard ECG or Holter monitoring;
- Eligible for both treatment arms;
- Signed and dated informed consent prior to admission to the trial.
Key exclusion criteria (10 listed)
- End-stage heart failure: NYHA class IV, patients on waiting list for cardiac transplant and/or left ventricular assist device;
- Long-standing (> 1 year) persistent or permanent AF;
- Previous pulmonary vein isolation or surgical ablation;
- Left atrial diameter ≥60 mm or left atrial volume index ≥50 ml/m2;
- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) ≤25 ml/min/1.73m2;
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 |
|---|---|---|
| Cryoballoon ablationAlso: Pulmonary vein isolation, PVI, CBAIf a patient is randomized to early invasive treatment, the ablation is performed within 3 months by an experienced cardiac electrophysiologist using CE-certified equipment. Via the femoral vein a guiding catheter is advanced through the inferior vena cava to the right atrium and into the left atrium via transseptal puncture. Then, the cryoballoon is advanced, inflated, and placed against one of the four PVs. PV occlusion is assessed by selective contrast injection. When adequate PV antral seal is confirmed, ablation of the tissue in contact with the balloon is performed using pressurized liquid nitrous oxide. The cold inflated balloon thus creates circular lesions around the PV. The balloon and tissue interface are then allowed to reach normal temperatures. Depending on local practice, the freeze-thaw cycle may be repeated twice. Electrical isolation is assessed and when it is confirmed, the next PV is treated in the same way. The procedure ends when all PV's are isolated. | Procedure or surgery | Early invasive treatment (cryoballoon ablation) |
Primary outcome
Composite of all-cause mortality, unplanned cardiovascular hospitalizations and stroke (time-to-event analysis)
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
5 secondary outcomes
Combined endpoint of all-cause mortality
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
Total number of unplanned cardiovascular hospitalizations and stroke (recurrent-event analysis)
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
Hierarchal endpoint of all-cause mortality, unplanned cardiovascular hospitalizations, stroke and change in heart failure complaints (hierarchical endpoint analysis)
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
Cost-effectiveness
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
Budget impact
Time frame: Study duration (1-5 years, expected median follow-up duration 2 years)
Results and safety
The study was stopped early (reason given: Insufficient enrollment speed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- 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. This study is not recruiting at the moment.
Kevin Vernooy, MD PhD study chair
Maastricht UMC+, Radboudumc
Michiel Rienstra, MD PhD study chair
UMC Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon ablation in people with Atrial Fibrillation and Heart Failure, run by Maastricht University at 2 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Insufficient enrollment speed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality, unplanned cardiovascular hospitalizations and stroke (time-to-event analysis) (time frame: Study duration (1-5 years, expected median follow-up duration 2 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 25 Jul 2025.