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

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01119716
• Collaborator: Institut für Herzinfarktforschung an der Universität Heidelberg (Other)
• Enrollment: 4,658
• Duration (Months): 33.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

Study Design

• Study Type: Observational
• Actual Enrollment: 4658 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: International Registry on Cardioversion of Atrial Fibrillation
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
All Enrolled Participants Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Outcome Measures

Primary Outcome Measures

1. Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission) [Baseline (time of admission)]

2. Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission) [Baseline (time of admission)]

3. Clinical Type of Atrial Fibrillation at Baseline (Admission) [Baseline (time of admission)]

4. Treatments Utilized for Participants for Atrial Fibrillation [At time of Treatment (up to 1 day from admission)]

5. Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion [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.

6. Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation [up to 60 days from day of treatment (cardioversion)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Planned cardioversion (of atrial fibrillation)

Exclusion Criteria:

• Already enrolled in this or any other clinical trial

• Atrial flutter

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC
• Institut für Herzinfarktforschung an der Universität Heidelberg

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01119716
• Other Study ID Numbers: 6621-051; 2010_025
• First Posted: May 7, 2010
• Last Update Posted: Nov 26, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Merck Sharp & Dohme LLC: Atrial Fibrillation; Afib; cardioversion; normal sinus rhythm; arrhythmia; AF
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options

Arm/Group Title	All Enrolled Participants
Arm/Group Description	Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Period Title: Overall Study
STARTED	4658
COMPLETED	4658
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Enrolled Participants
Arm/Group Description	Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Overall Participants	4658
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.5 (12.5)
Sex: Female, Male (Count of Participants)
Female	1742 37.4%
Male	2916 62.6%

Outcome Measures

1. Primary Outcome

Title	Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Time Frame	Baseline (time of admission)

Outcome Measure Data

Analysis Population Description

All enrolled participants with baseline cardiovascular history data.

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2909	1740	4649
Congenital Heart Disease	1.3 0%	1.6 NaN	1.4 NaN
Sick Sinus Syndrome	2.3 0%	3.5 NaN	2.8 NaN
Sustained Ventricular Tachycardia	1.2 0%	0.5 NaN	0.9 NaN
Ventricular Fibrillation	0.7 0%	0.4 NaN	0.6 NaN

2. Primary Outcome

Title	Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Time Frame	Baseline (time of admission)

Outcome Measure Data

Analysis Population Description

All enrolled participants with co-morbity data available.

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2851	1711	4562
Chronic Obstructive Pulmonary Disease	7.8 0.2%	7.1 NaN	7.5 NaN
Peripheral Vascular Disease	6.3 0.1%	5.1 NaN	5.8 NaN
Chronic Renal Failure	6.7 0.1%	5.3 NaN	6.2 NaN
Anemia	3.6 0.1%	5.3 NaN	4.2 NaN
Sleep Apnea Syndrome	4.8 0.1%	2.1 NaN	3.8 NaN
Haemorrhagic Complication	1.2 0%	1.8 NaN	1.4 NaN

3. Primary Outcome

Title	Clinical Type of Atrial Fibrillation at Baseline (Admission)
Time Frame	Baseline (time of admission)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2909	1740	4649
1st Detected Episode	29.2 0.6%	33.6 NaN	30.8 NaN
Paroxysmal	27.2 0.6%	31.9 NaN	28.9 NaN
Persistent	36.4 0.8%	27.6 NaN	33.1 NaN
Permanent	4.2 0.1%	3.6 NaN	4.0 NaN
Unknown	3.0 0.1%	3.3 NaN	3.1 NaN

4. Primary Outcome

Title	Treatments Utilized for Participants for Atrial Fibrillation
Time Frame	At time of Treatment (up to 1 day from admission)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2916	1742	4658
Electrical Cardioversion	1677 36%	792 NaN	2469 NaN
Pharmacological Cardioversion	705 15.1%	609 NaN	1314 NaN
Combined Electrical/Pharmacological Cardioversion	120 2.6%	69 NaN	189 NaN
Rate Control Change	215 4.6%	152 NaN	367 NaN
Catheter Ablation	92 2%	32 NaN	124 NaN
Surgical Therapy	1 0%	0 NaN	1 NaN
Implantable Cardiac Defibrillator	10 0.2%	0 NaN	10 NaN
Pacemaker	20 0.4%	18 NaN	38 NaN
No Treatment	550 11.8%	342 NaN	892 NaN

5. Primary Outcome

Title	Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
Description	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.
Time Frame	At time of treatment (up to 1 day from admission)

Outcome Measure Data

Analysis Population Description

Participants who had artrial fibrillation treated by either electrical or pharmacological cardioversion.

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed	Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2262	1332	3594
Electrical Cardioversion	69.5 1.5%	55.1 NaN	64.2 NaN
Pharmacological Cardioversion	30.5 0.7%	44.9 NaN	35.8 NaN

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

All enrolled participants with follow-up data available

Arm/Group Title	Male	Female	Total
Arm/Group Description	Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options	All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Measure Participants	2633	1507	4140
Myocardial Infarction	2 0%	2 NaN	4 NaN
Non-haemorrhagic Stroke	7 0.2%	3 NaN	10 NaN
Haemorrhagic Stroke	1 0%	0 NaN	1 NaN
Peripheral Embolism	0 0%	2 NaN	2 NaN
Pulmonary Embolism	1 0%	3 NaN	4 NaN
Transient Ischaemic Attack	0 0%	1 NaN	1 NaN
Heart Failure	9 0.2%	10 NaN	19 NaN
Major Bleeding	3 0.1%	3 NaN	6 NaN
Minor Bleeding	12 0.3%	6 NaN	18 NaN
Recurrence of Atrial Fibrillation	107 2.3%	63 NaN	170 NaN
Recurrence of Atrial Flutter	10 0.2%	2 NaN	12 NaN
Asystole for more than 3 seconds	2 0%	2 NaN	4 NaN
Symptomatic Ventricular Tachycardia	0 0%	1 NaN	1 NaN
Ventricular Fibrillation	2 0%	1 NaN	3 NaN
Sick Sinus syndrome	1 0%	2 NaN	3 NaN
Torsade de pointes	0 0%	1 NaN	1 NaN
Syncope	5 0.1%	4 NaN	9 NaN
Endocarditis	0 0%	1 NaN	1 NaN
Tamponade	1 0%	0 NaN	1 NaN
Bradycardia	4 0.1%	0 NaN	4 NaN
Hypotension	4 0.1%	1 NaN	5 NaN
Other Complication	27 0.6%	18 NaN	45 NaN
Death	198 4.3%	113 NaN	311 NaN

Adverse Events

Adverse Event Reporting Description	No formal reporting or recording of adverse events was conducted during this observational study.
Arm/Group Title	All Enrolled Participants
Arm/Group Description	Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
All Cause Mortality
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Scientific Committee for the study has the authority to make all decisions related to design, conduct, data interpretation and dissemination of study results.