NCT01119716: RHYTHM-AF

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

Completed Results posted Last updated 12 June 2024

What this trial tests

trial in Atrial Fibrillation in 4,658 participants. Completed in 15 February 2013.

Timeline

25 May 2010

Primary endpoint
15 February 2013

15 February 2013

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,658
Start date	25 May 2010
Primary completion	15 February 2013
Estimated completion	15 February 2013

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) Primary · Baseline (time of admission)

Congenital Heart Disease

Group	Value	95% CI
Male	1.3
Female	1.6
Total	1.4

Sick Sinus Syndrome

Group	Value	95% CI
Male	2.3
Female	3.5
Total	2.8

Sustained Ventricular Tachycardia

Group	Value	95% CI
Male	1.2
Female	0.5
Total	0.9

Ventricular Fibrillation

Group	Value	95% CI
Male	0.7
Female	0.4
Total	0.6

Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission) Primary · Baseline (time of admission)

Chronic Obstructive Pulmonary Disease

Group	Value	95% CI
Male	7.8
Female	7.1
Total	7.5

Peripheral Vascular Disease

Group	Value	95% CI
Male	6.3
Female	5.1
Total	5.8

Chronic Renal Failure

Group	Value	95% CI
Male	6.7
Female	5.3
Total	6.2

Anemia

Group	Value	95% CI
Male	3.6
Female	5.3
Total	4.2

Sleep Apnea Syndrome

Group	Value	95% CI
Male	4.8
Female	2.1
Total	3.8

Haemorrhagic Complication

Group	Value	95% CI
Male	1.2
Female	1.8
Total	1.4

Clinical Type of Atrial Fibrillation at Baseline (Admission) Primary · Baseline (time of admission)

1st Detected Episode

Group	Value	95% CI
Male	29.2
Female	33.6
Total	30.8

Paroxysmal

Group	Value	95% CI
Male	27.2
Female	31.9
Total	28.9

Persistent

Group	Value	95% CI
Male	36.4
Female	27.6
Total	33.1

Permanent

Group	Value	95% CI
Male	4.2
Female	3.6
Total	4.0

Unknown

Group	Value	95% CI
Male	3.0
Female	3.3
Total	3.1

Treatments Utilized for Participants for Atrial Fibrillation Primary · At time of Treatment (up to 1 day from admission)

Electrical Cardioversion

Group	Value	95% CI
Male	1677
Female	792
Total	2469

Pharmacological Cardioversion

Group	Value	95% CI
Male	705
Female	609
Total	1314

Combined Electrical/Pharmacological Cardioversion

Group	Value	95% CI
Male	120
Female	69
Total	189

Rate Control Change

Group	Value	95% CI
Male	215
Female	152
Total	367

Catheter Ablation

Group	Value	95% CI
Male	92
Female	32
Total	124

Surgical Therapy

Group	Value	95% CI
Male	1
Female	0
Total	1

Implantable Cardiac Defibrillator

Group	Value	95% CI
Male	10
Female	0
Total	10

Pacemaker

Group	Value	95% CI
Male	20
Female	18
Total	38

Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion Primary · 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.

Electrical Cardioversion

Group	Value	95% CI
Male	69.5
Female	55.1
Total	64.2

Pharmacological Cardioversion

Group	Value	95% CI
Male	30.5
Female	44.9
Total	35.8

Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation Primary · up to 60 days from day of treatment (cardioversion)

Myocardial Infarction

Group	Value	95% CI
Male	2
Female	2
Total	4

Non-haemorrhagic Stroke

Group	Value	95% CI
Male	7
Female	3
Total	10

Haemorrhagic Stroke

Group	Value	95% CI
Male	1
Female	0
Total	1

Peripheral Embolism

Group	Value	95% CI
Male	0
Female	2
Total	2

Pulmonary Embolism

Group	Value	95% CI
Male	1
Female	3
Total	4

Transient Ischaemic Attack

Group	Value	95% CI
Male	0
Female	1
Total	1

Heart Failure

Group	Value	95% CI
Male	9
Female	10
Total	19

Major Bleeding

Group	Value	95% CI
Male	3
Female	3
Total	6

Sponsor's own description

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 and their combinations), and associated complications within 60 days after enrollment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. RHYTHM-AF: design of an international registry on cardioversion of atrial fibrillation and characteristics of participating centers.
   Crijns HJ, Bash LD, Chazelle F, Le Heuzey JY, et al · · 2012 · cited 20× · PMID 23031215 · DOI 10.1186/1471-2261-12-85