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Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Rate control
Pharmacological or electrical cardioversion
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Cardiac arrhythmia, Cardioversion, Electrical cardioversion, Watchful waiting, Wait-and-see, Telemonitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of untreated Sick Sinus Syndrome
  • History of untreated Wolff-Parkinson-White syndrome
  • Currently enrolled in another clinical trial

Sites / Locations

  • Maastricht University Medical CenterRecruiting
  • Noordwest ZiekenhuisgroepRecruiting
  • Vrije Universiteit Medisch CentrumRecruiting
  • RijnstateRecruiting
  • Medisch Spectrum TwenteRecruiting
  • Martini ZiekenhuisRecruiting
  • Universitair Medisch Centrum GroningenRecruiting
  • Zuyderland Medisch CentrumRecruiting
  • Alrijne ZiekenhuisRecruiting
  • St Antonius ZiekenhuisRecruiting
  • Radboud UMCRecruiting
  • Antonius ZiekenhuisRecruiting
  • St. Elisabeth TweeSteden ZiekenhuisRecruiting
  • VieCuri Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Watchful waiting

Routine care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of sinus rhythm
Sinus rhythm documented on a 12-lead ECG

Secondary Outcome Measures

Implementation of the telemonitoring infrastructure
e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system
MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events
e.g. hospitalisation for stroke, myocardial infarction
AF recurrences/AF progression
e.g. number of AF recurrences, progression to persistent AF
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.
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.
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.
Rate and rhythm control interventions (number of)
Alert- and patient-triggered
Rhythm control interventions
Number of participants with cardioversion, catheter ablation

Full Information

First Posted
August 17, 2020
Last Updated
March 14, 2023
Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, Netherlands Organisation for Scientific Research
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1. Study Identification

Unique Protocol Identification Number
NCT04612335
Brief Title
Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Dutch Heart Foundation, Netherlands Organisation for Scientific Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Cardiac arrhythmia, Cardioversion, Electrical cardioversion, Watchful waiting, Wait-and-see, Telemonitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
490 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Watchful waiting
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Rate control
Intervention Description
Rate control drugs are administered to obtain symptom relief and a heart rate of <110 bpm, followed by a 4-week telemonitoring period.
Intervention Type
Other
Intervention Name(s)
Pharmacological or electrical cardioversion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of sinus rhythm
Description
Sinus rhythm documented on a 12-lead ECG
Time Frame
4 weeks after inclusion
Secondary Outcome Measure Information:
Title
Implementation of the telemonitoring infrastructure
Description
e.g. use of telemonitoring infrastructure during the 4 weeks follow up, accuracy of alert system
Time Frame
4 weeks
Title
MACCE: major cardiovascular mortality and cardiovascular and cerebrovascular events
Description
e.g. hospitalisation for stroke, myocardial infarction
Time Frame
1 year
Title
AF recurrences/AF progression
Description
e.g. number of AF recurrences, progression to persistent AF
Time Frame
4 weeks and 1 year
Title
Cost-effectiveness
Description
The costs and cost-effectiveness of the new approach will be determined and compared to the costs and cost-effectiveness of routine care.
Time Frame
1 year
Title
Questionnaires on quality of life (SF-36)
Description
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.
Time Frame
1 year
Title
Patient reported experiences
Description
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.
Time Frame
1 year
Title
Rate and rhythm control interventions (number of)
Description
Alert- and patient-triggered
Time Frame
4 weeks
Title
Rhythm control interventions
Description
Number of participants with cardioversion, catheter ablation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 History of untreated Sick Sinus Syndrome History of untreated Wolff-Parkinson-White syndrome Currently enrolled in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel MJ van der Velden, MD
Phone
31433876885
Email
rachel.vander.velden@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Nikki AH Pluymaekers, MD
Phone
31433875119
Email
nikki.pluymaekers@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry JG Crijns, MD, PhD
Organizational Affiliation
Head of cardiology department, Maastricht University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dominik Linz, MD, PhD
Organizational Affiliation
Head of cardiac electrophysiology, Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229AX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel van der Velden, MD
Phone
+31433876885
Email
rachel.vander.velden@mumc.nl
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
State/Province
Noord-Holland
ZIP/Postal Code
1815JD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Timmer
Facility Name
Vrije Universiteit Medisch Centrum
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
O Kamp
Facility Name
Rijnstate
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Hemels
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J van Opstal
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Tieleman
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I van Gelder
Facility Name
Zuyderland Medisch Centrum
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T Lenderink
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Kirchhof
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V van Dijk
Facility Name
Radboud UMC
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Beukema
Facility Name
Antonius Ziekenhuis
City
Sneek
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A Oomen
Facility Name
St. Elisabeth TweeSteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Widdershoven
Facility Name
VieCuri Medical Centre
City
Venlo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W Heesen

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All elements from the CRF matching a future project's CRF may be provided for an aggregated analysis.
IPD Sharing Time Frame
Well after publication of main paper
IPD Sharing Access Criteria
Please contact principal investigator or study chair.

Learn more about this trial

Device-based Rate Versus Rhythm Control in Symptomatic Recent-onset Atrial Fibrillation (RACE 9 OBSERVE-AF)

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