Trial Outcomes & Findings for International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051) (NCT NCT01119716)
NCT ID: NCT01119716
Last Updated: 2024-06-12
Results Overview
Recruitment status
COMPLETED
Target enrollment
4658 participants
Primary outcome timeframe
Baseline (time of admission)
Results posted on
2024-06-12
Participant Flow
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
Participant milestones
| Measure |
All Enrolled Participants
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|
|
Overall Study
STARTED
|
4658
|
|
Overall Study
COMPLETED
|
4658
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
International Registry on Cardioversion of Atrial Fibrillation (MK-6621-051)
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=4658 Participants
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1742 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2916 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (time of admission)Population: All enrolled participants with baseline cardiovascular history data.
Outcome measures
| Measure |
Male
n=2909 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1740 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=4649 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Congenital Heart Disease
|
1.3 Percentage of Participants
|
1.6 Percentage of Participants
|
1.4 Percentage of Participants
|
|
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Sick Sinus Syndrome
|
2.3 Percentage of Participants
|
3.5 Percentage of Participants
|
2.8 Percentage of Participants
|
|
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Sustained Ventricular Tachycardia
|
1.2 Percentage of Participants
|
0.5 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Ventricular Fibrillation
|
0.7 Percentage of Participants
|
0.4 Percentage of Participants
|
0.6 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline (time of admission)Population: All enrolled participants with co-morbity data available.
Outcome measures
| Measure |
Male
n=2851 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1711 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=4562 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Chronic Obstructive Pulmonary Disease
|
7.8 Percentage of Participants
|
7.1 Percentage of Participants
|
7.5 Percentage of Participants
|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Peripheral Vascular Disease
|
6.3 Percentage of Participants
|
5.1 Percentage of Participants
|
5.8 Percentage of Participants
|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Chronic Renal Failure
|
6.7 Percentage of Participants
|
5.3 Percentage of Participants
|
6.2 Percentage of Participants
|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Anemia
|
3.6 Percentage of Participants
|
5.3 Percentage of Participants
|
4.2 Percentage of Participants
|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Sleep Apnea Syndrome
|
4.8 Percentage of Participants
|
2.1 Percentage of Participants
|
3.8 Percentage of Participants
|
|
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)
Haemorrhagic Complication
|
1.2 Percentage of Participants
|
1.8 Percentage of Participants
|
1.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline (time of admission)Population: All enrolled participants with admission (baseline) atrial fibrillation data available.
Outcome measures
| Measure |
Male
n=2909 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1740 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=4649 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Persistent
|
36.4 Percentage of Participants
|
27.6 Percentage of Participants
|
33.1 Percentage of Participants
|
|
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Permanent
|
4.2 Percentage of Participants
|
3.6 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Unknown
|
3.0 Percentage of Participants
|
3.3 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Clinical Type of Atrial Fibrillation at Baseline (Admission)
1st Detected Episode
|
29.2 Percentage of Participants
|
33.6 Percentage of Participants
|
30.8 Percentage of Participants
|
|
Clinical Type of Atrial Fibrillation at Baseline (Admission)
Paroxysmal
|
27.2 Percentage of Participants
|
31.9 Percentage of Participants
|
28.9 Percentage of Participants
|
PRIMARY outcome
Timeframe: At time of Treatment (up to 1 day from admission)Population: All enrolled participants with available data pertaining to type of therapy(s) used to treat the participants atrial fibrillation.
Outcome measures
| Measure |
Male
n=2916 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1742 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=4658 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Treatments Utilized for Participants for Atrial Fibrillation
Electrical Cardioversion
|
1677 Participants
|
792 Participants
|
2469 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Pharmacological Cardioversion
|
705 Participants
|
609 Participants
|
1314 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Combined Electrical/Pharmacological Cardioversion
|
120 Participants
|
69 Participants
|
189 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Rate Control Change
|
215 Participants
|
152 Participants
|
367 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Catheter Ablation
|
92 Participants
|
32 Participants
|
124 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Surgical Therapy
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Implantable Cardiac Defibrillator
|
10 Participants
|
0 Participants
|
10 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
Pacemaker
|
20 Participants
|
18 Participants
|
38 Participants
|
|
Treatments Utilized for Participants for Atrial Fibrillation
No Treatment
|
550 Participants
|
342 Participants
|
892 Participants
|
PRIMARY outcome
Timeframe: At time of treatment (up to 1 day from admission)Population: Participants who had artrial fibrillation treated by either 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.
Outcome measures
| Measure |
Male
n=2262 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1332 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=3594 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
Electrical Cardioversion
|
69.5 Percentage of Participants
|
55.1 Percentage of Participants
|
64.2 Percentage of Participants
|
|
Percentage of Participants Who Had a Successful Electrical or Pharmacological Cardioversion
Pharmacological Cardioversion
|
30.5 Percentage of Participants
|
44.9 Percentage of Participants
|
35.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 60 days from day of treatment (cardioversion)Population: All enrolled participants with follow-up data available
Outcome measures
| Measure |
Male
n=2633 Participants
Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Female
n=1507 Participants
Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
Total
n=4140 Participants
All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
|
|---|---|---|---|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Myocardial Infarction
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Non-haemorrhagic Stroke
|
7 Participants
|
3 Participants
|
10 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Haemorrhagic Stroke
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Peripheral Embolism
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Pulmonary Embolism
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Transient Ischaemic Attack
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Heart Failure
|
9 Participants
|
10 Participants
|
19 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Major Bleeding
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Minor Bleeding
|
12 Participants
|
6 Participants
|
18 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Recurrence of Atrial Fibrillation
|
107 Participants
|
63 Participants
|
170 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Recurrence of Atrial Flutter
|
10 Participants
|
2 Participants
|
12 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Asystole for more than 3 seconds
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Symptomatic Ventricular Tachycardia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Ventricular Fibrillation
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Sick Sinus syndrome
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Torsade de pointes
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Syncope
|
5 Participants
|
4 Participants
|
9 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Endocarditis
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Tamponade
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Bradycardia
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Hypotension
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Other Complication
|
27 Participants
|
18 Participants
|
45 Participants
|
|
Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation
Death
|
198 Participants
|
113 Participants
|
311 Participants
|
Adverse Events
All Enrolled Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Scientific Committee for the study has the authority to make all decisions related to design, conduct, data interpretation and dissemination of study results.
- Publication restrictions are in place
Restriction type: OTHER