Atrial FibrillationRHYTHM-AFNCT01119716

International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)

An observational study of Atrial Fibrillation, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will create a prospective registry of consecutive patients with Atrial Fibrillation (Afib) considered for cardioversion treatment to document up-to-date practice of in-hospital treatment, with a focus on the characterization of type of Afib, as well as on treatments applied (drugs, devices, interventions… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 4,658 participants
Where: No sites listed yet
Study dates: 25 May 2010to 15 Feb 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: Patients in a hospital setting in Australia, Brazil, France, Germany, Italy, Netherlands, Poland, UK, Spain, and Sweden from a cross section of different centers including university and non-university hospitals.

Who may be able to join

Participant with documented atrial fibrillation (confirmed by electrocardiogram) in the hospital setting at the time of enrollment
Planned cardioversion (of atrial fibrillation)

Who cannot join

Already enrolled in this or any other clinical trial
Atrial flutter

About this study

Official title: International Registry on Cardioversion of Atrial Fibrillation

Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation, Afib, cardioversion, normal sinus rhythm, arrhythmia, AF
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.

Study groups in NCT01119716
Study group	Role	What they receive
All Enrolled Participants		Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Measured: Baseline (time of admission)
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Measured: Baseline (time of admission)
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Measured: Baseline (time of admission)
Treatments Utilized for Participants for Atrial Fibrillation
Measured: At time of Treatment (up to 1 day from admission)
Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.
Measured: At time of treatment (up to 1 day from admission)
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Measured: up to 60 days from day of treatment (cardioversion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201015 Feb 2013

First posted7 May 2010 (estimated)
Study start25 May 2010
Primary completion15 Feb 2013
Study completion15 Feb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 4,658 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119716
Sponsor's protocol ID: 6621-051
Other IDs: 2010_025
Acronym: RHYTHM-AF
Status last verified: May 2024
First submitted: 6 May 2010
Last updated: 12 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25.
PubMed 24556445
Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85.
PubMed 23031215

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: International Registry on Cardioversion of Atrial Fibrillation
ClinicalTrials.gov ID: NCT01119716
Acronym / sponsor ID: RHYTHM-AF / 6621-051
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation, Afib, cardioversion, normal sinus rhythm, arrhythmia, AF
Study type: Observational
Recruitment status: Completed
Enrolment: 4,658 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: Institut für Herzinfarktforschung an der Universität Heidelberg
Study start: 25 May 2010 (actual)
Primary completion: 15 Feb 2013 (actual)
Study completion: 15 Feb 2013 (actual)
First posted: 7 May 2010 (estimated)
Results: Posted 30 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Enrolled Participants	–	–Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients in a hospital setting in Australia, Brazil, France, Germany, Italy, Netherlands, Poland, UK, Spain, and Sweden from a cross section of different centers including university and non-university hospitals.

Key inclusion criteria (2 listed)

Participant with documented atrial fibrillation (confirmed by electrocardiogram) in the hospital setting at the time of enrollment
Planned cardioversion (of atrial fibrillation)

Key exclusion criteria (2 listed)

Already enrolled in this or any other clinical trial
Atrial flutter

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Time frame: Baseline (time of admission)
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Time frame: Baseline (time of admission)
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Time frame: Baseline (time of admission)
Treatments Utilized for Participants for Atrial Fibrillation
Time frame: At time of Treatment (up to 1 day from admission)
Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
Time frame: At time of treatment (up to 1 day from admission)
Pharmacological cardioversion was considered successful if sinus rhythm or atrial rhythm was obtained within 24 hours after its initiation. Electrical cardioversion was considered successful if sinus rhythm was obtained and maintained for at least 10 minutes after the last shock was administered.
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Time frame: up to 60 days from day of treatment (cardioversion)

Results and safety

Results posted to the registry on 30 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Participants	4,658	4,658

Primary outcome: Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)

Time frame: Baseline (time of admission). Number. Unit: Percentage of Participants

Measure	Male n = 2909	Female n = 1740	Total n = 4649
Congenital Heart Disease	1.3	1.6	1.4
Sick Sinus Syndrome	2.3	3.5	2.8
Sustained Ventricular Tachycardia	1.2	0.5	0.9
Ventricular Fibrillation	0.7	0.4	0.6

Population analysed: All enrolled participants with baseline cardiovascular history data.

Primary outcome: Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)

Time frame: Baseline (time of admission). Number. Unit: Percentage of Participants

Measure	Male n = 2851	Female n = 1711	Total n = 4562
Chronic Obstructive Pulmonary Disease	7.8	7.1	7.5
Peripheral Vascular Disease	6.3	5.1	5.8
Chronic Renal Failure	6.7	5.3	6.2
Anemia	3.6	5.3	4.2
Sleep Apnea Syndrome	4.8	2.1	3.8
Haemorrhagic Complication	1.2	1.8	1.4

Population analysed: All enrolled participants with co-morbity data available.

Primary outcome: Clinical Type of Atrial Fibrillation at Baseline (Admission)

Time frame: Baseline (time of admission). Number. Unit: Percentage of Participants

Measure	Male n = 2909	Female n = 1740	Total n = 4649
1st Detected Episode	29.2	33.6	30.8
Paroxysmal	27.2	31.9	28.9
Persistent	36.4	27.6	33.1
Permanent	4.2	3.6	4.0
Unknown	3.0	3.3	3.1

Population analysed: All enrolled participants with admission (baseline) atrial fibrillation data available.

Primary outcome: Treatments Utilized for Participants for Atrial Fibrillation

Time frame: At time of Treatment (up to 1 day from admission). Number. Unit: Participants

Measure	Male n = 2916	Female n = 1742	Total n = 4658
Electrical Cardioversion	1677	792	2469
Pharmacological Cardioversion	705	609	1314
Combined Electrical/Pharmacological Cardioversion	120	69	189
Rate Control Change	215	152	367
Catheter Ablation	92	32	124
Surgical Therapy	1	0	1
Implantable Cardiac Defibrillator	10	0	10
Pacemaker	20	18	38

Population analysed: All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Participants	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24556445Crijns HJ, Weijs B, Fairley AM, Lewalter T, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bash LD, Chazelle F, Bernhardt A, Gitt AK, Lip GY, Le Heuzey JY. Contemporary real life cardioversion of atrial fibrillation: Results from the multinational RHYTHM-AF study. Int J Cardiol. 2014 Apr 1;172(3):588-94. doi: 10.1016/j.ijcard.2014.01.099. Epub 2014 Jan 25.
Derived from this study: PubMed 23031215Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, Lewalter T, Lip GY, Maggioni AP, Martin A, Ponikowski P, Rosenqvist M, Sanders P, Scanavacca M, Bernhardt AA, Unniachan S, Phatak HM, Gitt AK. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers. BMC Cardiovasc Disord. 2012 Oct 2;12:85. doi: 10.1186/1471-2261-12-85.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Merck Sharp & Dohme LLC.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) (time frame: Baseline (time of admission)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01119716, which also lists 2 linked publications.

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 12 Jun 2024.