Atrial FibrillationNCT04612335
Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
A study testing Pharmacological or electrical cardioversion in people with Atrial Fibrillation, run by Maastricht University Medical Center at 14 sites in Netherlands.
Trial summary
Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) allows spontaneous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pharmacological or electrical cardioversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 14 sitesNetherlands
- Study dates
- 16 Nov 2020to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECG with atrial fibrillation
- Duration of the current AF episode <36 hours
- Symptoms due to atrial fibrillation
- Age > 18 years
- Able and willing to sign informed consent
- Able and willing to use telemetric rhythm recorder
Who cannot join
- History of persistent AF (episode of AF lasting more than 48 hours and terminated by cardioversion)
- Deemed unsuitable for participation by attending physician
- Hemodynamic instability (heart rate >170 bpm, systolic blood pressure <100 mmHg)
- Acute heart failure
- Signs of myocardial infarction
- History of syncope of unexplained origin
Show all 9Show fewer
- History of untreated Sick Sinus Syndrome
- History of untreated Wolff-Parkinson-White syndrome
- Currently enrolled in another clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Netherlands14 sites, 14 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815JD
S Timmer
- Recruiting
Vrije Universiteit Medisch Centrum
Amsterdam
O Kamp
- Recruiting
Rijnstate
Arnhem
M Hemels
- Recruiting
Medisch Spectrum Twente
Enschede
J van Opstal
- Recruiting
Martini Ziekenhuis
Groningen
R Tieleman
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
I van Gelder
- Recruiting
Zuyderland Medisch Centrum
Heerlen
T Lenderink
- Recruiting
Alrijne Ziekenhuis
Leiderdorp
C Kirchhof
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229AX
Rachel van der Velden, MD, +31433876885, rachel.vander.velden@mumc.nl
- Recruiting
St Antonius Ziekenhuis
Nieuwegein
V van Dijk
- Recruiting
Radboud UMC
Nijmegen
R Beukema
- Recruiting
Antonius Ziekenhuis
Sneek
A Oomen
- Recruiting
St. Elisabeth TweeSteden Ziekenhuis
Tilburg
J Widdershoven
- Recruiting
VieCuri Medical Centre
Venlo
W Heesen
About this study
Official title: Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)
Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time. Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.
Read the detailed description
Until recently standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. This has just been expanded with a delayed cardioversion approach. However, considering the recurrent and transient nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to accomplish spontaneous conversion to sinus rhythm. The aim of this trial is to evaluate effectiveness (presence of sinus rhythm) of a watchful-waiting approach, i.e. symptom reduction through rate-control medication and monitoring until spontaneous conversion is achieved compared to routine care, consisting of either early or delayed cardioversion. The trial is a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to routine care (control).The primary endpoint (presence of sinus rhythm), will be assessed after 4 weeks. The total follow-up time is 1 year.
- Conditions
- Atrial Fibrillation
- Being tested
- Rate control, Pharmacological or electrical cardioversion
- Keywords
- Atrial fibrillation, Cardiac arrhythmia, Cardioversion, Electrical cardioversion, Watchful waiting, Wait-and-see, Telemonitoring
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate controlOther
Rate control drugs are administered to obtain symptom relief and a heart rate of <110 bpm, followed by a 4-week telemonitoring period.
Pharmacological or electrical cardioversionOther
Pharmacological or electrical cardioversion is performed to achieve restoration of sinus rhythm, either acutely or in a wait-and-see approach, all within 48 hours, and followed by a 4-week telemonitoring period.
| Study group | Role | What they receive |
|---|---|---|
| Watchful waiting | Experimental | the watchful-waiting approach consists of administration of rate control medication to obtain relief of symptoms and a heart rate <110 beats per minute, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy. Receives: Other: Rate control |
| Routine care | Other | Routine care consists of the standard treatment for an acute episode of recent-onset symptomatic atrial fibrillation, namely acute or delayed cardioversion, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy. Receives: Other: Pharmacological or electrical cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of sinus rhythm
Sinus rhythm documented on a 12-lead ECG
Measured: 4 weeks after inclusion
Secondary outcomes (8)
Implementation of the telemonitoring infrastructure
e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system
Measured: 4 weeks
MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events
e.g. hospitalisation for stroke, myocardial infarction
Measured: 1 year
AF recurrences/AF progression
e.g. number of AF recurrences, progression to persistent AF
Measured: 4 weeks and 1 year
Cost-effectiveness
The costs and cost-effectiveness of the new approach will be determined and compared to the costs and cost-effectiveness of routine care.
Measured: 1 year
Questionnaires on quality of life (SF-36)
Questionnaires on quality of life (e.g. SF-36), will be used to assess whether there are differences between the two arms. The SF-36 will be evaluated according to recommendations; scores will be recoded on a scale of 0-100 and averaged. Higher scores indicate better quality of life.
Measured: 1 year
Patient reported experiences
A questionnaire on patient reported experiences with the telemonitoring device will be used to assess whether there are differences between the two arms. There will be both positively orientated, and negatively orientated questionnes which have to be rated on a scale of 1-5.
Measured: 1 year
Rate and rhythm control interventions (number of)
Alert- and patient-triggered
Measured: 4 weeks
Rhythm control interventions
Number of participants with cardioversion, catheter ablation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start16 Nov 2020
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, Netherlands Organisation for Scientific Research
- Responsible party
- Sponsor
- Investigators
- Harry JG Crijns, MD, PhD, Study chair, Head of cardiology department, Maastricht University Medical CenterDominik Linz, MD, PhD, Principal investigator, Head of cardiac electrophysiology, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612335
- Sponsor's protocol ID
- NL73104.068.20
- Status last verified
- Mar 2024
- First submitted
- 17 Aug 2020
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All elements from the CRF matching a future project's CRF may be provided for an aggregated analysis.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device-based Rate Versus Rhythm Control Treatment in Patients With Symptomatic Recent-onset Atrial Fibrillation in the Emergency Department (RACE 9 OBSERVE-AF)
- ClinicalTrials.gov ID
- NCT04612335
- Acronym / sponsor ID
- NL73104.068.20
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cardiac arrhythmia, Cardioversion, Electrical cardioversion, Watchful waiting, Wait-and-see, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, Netherlands Organisation for Scientific Research
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 2 Nov 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.
Continuous heart rhythm monitoring elucidated the recurrent and transient nature of recent-onset atrial fibrillation (AF). The RACE7 ACWAS showed that a wait-and-see approach (WAS) in patients with recent-onset AF (rate control for symptom relief followed by delayed cardioversion if needed <48h) allows spontaneous conversion to sinus rhythm in 69% of patients, obviating active cardioversion. Recurrences within one month were seen in 30% of patients in both groups, i.e. the initially chosen strategy did not affect the recurrence pattern. Considering the latter, it remains unclear whether cardioversion is needed at all, especially since cardioversion strategy does not seem to affect behaviour of the arrhythmia over time. Instead of cardioversion a watchful-waiting rate control strategy may be appropriate as initial strategy. This allows observing the electrical and clinical behavior of arrhythmia, providing a solid basis for comprehensive and effective early rhythm control. This study is a multi-center clinical randomized controlled trial to show non-inferiority of watchful-waiting with rate control versus routine care in terms of prevalence of sinus rhythm at 4 weeks follow-up, using a novel telemonitoring infrastructure to guide rate control during follow-up.
Detailed description
Until recently standard of care for patients with recent-onset atrial fibrillation (AF) was early cardioversion. This has just been expanded with a delayed cardioversion approach. However, considering the recurrent and transient nature of AF, cardioversion might not be needed at all and rate control medication might be sufficient to accomplish spontaneous conversion to sinus rhythm. The aim of this trial is to evaluate effectiveness (presence of sinus rhythm) of a watchful-waiting approach, i.e. symptom reduction through rate-control medication and monitoring until spontaneous conversion is achieved compared to routine care, consisting of either early or delayed cardioversion. The trial is a multicentre prospective, randomized, open label, non-inferiority trial comparing the interventional watchful-waiting approach to routine care (control).The primary endpoint (presence of sinus rhythm), will be assessed after 4 weeks. The total follow-up time is 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Watchful waiting | Experimental | Other: Rate controlthe watchful-waiting approach consists of administration of rate control medication to obtain relief of symptoms and a heart rate <110 beats per minute, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy. |
| Routine care | Other | Other: Pharmacological or electrical cardioversionRoutine care consists of the standard treatment for an acute episode of recent-onset symptomatic atrial fibrillation, namely acute or delayed cardioversion, followed by a telemetric rhythm monitoring period of four weeks to guide rate control therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECG with atrial fibrillation
- Duration of the current AF episode <36 hours
- Symptoms due to atrial fibrillation
- Age > 18 years
- Able and willing to sign informed consent
Key exclusion criteria (9 listed)
- History of persistent AF (episode of AF lasting more than 48 hours and terminated by cardioversion)
- Deemed unsuitable for participation by attending physician
- Hemodynamic instability (heart rate >170 bpm, systolic blood pressure <100 mmHg)
- Acute heart failure
- Signs of myocardial infarction
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 |
|---|---|---|
| Rate controlRate control drugs are administered to obtain symptom relief and a heart rate of <110 bpm, followed by a 4-week telemonitoring period. | Other | Watchful waiting |
| Pharmacological or electrical cardioversionPharmacological or electrical cardioversion is performed to achieve restoration of sinus rhythm, either acutely or in a wait-and-see approach, all within 48 hours, and followed by a 4-week telemonitoring period. | Other | Routine care |
Primary outcome
Presence of sinus rhythm
Time frame: 4 weeks after inclusion
Sinus rhythm documented on a 12-lead ECG
8 secondary outcomes
Implementation of the telemonitoring infrastructure
Time frame: 4 weeks
MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events
Time frame: 1 year
AF recurrences/AF progression
Time frame: 4 weeks and 1 year
Cost-effectiveness
Time frame: 1 year
Questionnaires on quality of life (SF-36)
Time frame: 1 year
Patient reported experiences
Time frame: 1 year
Rate and rhythm control interventions (number of)
Time frame: 4 weeks
Rhythm control interventions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Yes. All elements from the CRF matching a future project's CRF may be provided for an aggregated analysis.
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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.
Harry JG Crijns, MD, PhD study chair
Head of cardiology department, Maastricht University Medical Center
Dominik Linz, MD, PhD principal investigator
Head of cardiac electrophysiology, Maastricht University Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological or electrical cardioversion in people with Atrial Fibrillation, run by Maastricht University Medical Center at 14 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel MJ van der Velden, MD (31433876885, rachel.vander.velden@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of sinus rhythm (time frame: 4 weeks after inclusion). 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 22 May 2024.