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

International Registry on Cardioversion of Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01119716
Acronym
RHYTHM-AF
Enrollment
4658
Registered
2010-05-07
Start date
2010-05-25
Completion date
2013-02-15
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, Afib, cardioversion, normal sinus rhythm, arrhythmia, AF

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.

Interventions

None listed

Sponsors

Institut für Herzinfarktforschung an der Universität Heidelberg
CollaboratorUNKNOWN
Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Baseline (time of admission)
Co-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Baseline (time of admission)
Clinical Type of Atrial Fibrillation at Baseline (Admission)Baseline (time of admission)
Treatments Utilized for Participants for Atrial FibrillationAt time of Treatment (up to 1 day from admission)
Percentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionAt 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 Fibrillationup to 60 days from day of treatment (cardioversion)

Participant flow

Recruitment details

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

Participants by arm

ArmCount
All Enrolled Participants
Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
4,658
Total4,658

Baseline characteristics

CharacteristicAll Enrolled Participants
Age, Continuous63.5 years
STANDARD_DEVIATION 12.5
Sex: Female, Male
Female
1742 Participants
Sex: Female, Male
Male
2916 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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

Time frame: Baseline (time of admission)

Population: All enrolled participants with baseline cardiovascular history data.

ArmMeasureGroupValue (NUMBER)
MaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Congenital Heart Disease1.3 Percentage of Participants
MaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sick Sinus Syndrome2.3 Percentage of Participants
MaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sustained Ventricular Tachycardia1.2 Percentage of Participants
MaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Ventricular Fibrillation0.7 Percentage of Participants
FemaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Ventricular Fibrillation0.4 Percentage of Participants
FemaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Congenital Heart Disease1.6 Percentage of Participants
FemaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sustained Ventricular Tachycardia0.5 Percentage of Participants
FemaleCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sick Sinus Syndrome3.5 Percentage of Participants
TotalCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Ventricular Fibrillation0.6 Percentage of Participants
TotalCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sick Sinus Syndrome2.8 Percentage of Participants
TotalCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sustained Ventricular Tachycardia0.9 Percentage of Participants
TotalCardiovascular Disease History of Participants Presenting With Atrial Fibrillation at Baseline (Admission)Congenital Heart Disease1.4 Percentage of Participants
Primary

Clinical Type of Atrial Fibrillation at Baseline (Admission)

Time frame: Baseline (time of admission)

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

ArmMeasureGroupValue (NUMBER)
MaleClinical Type of Atrial Fibrillation at Baseline (Admission)Permanent4.2 Percentage of Participants
MaleClinical Type of Atrial Fibrillation at Baseline (Admission)Persistent36.4 Percentage of Participants
MaleClinical Type of Atrial Fibrillation at Baseline (Admission)1st Detected Episode29.2 Percentage of Participants
MaleClinical Type of Atrial Fibrillation at Baseline (Admission)Paroxysmal27.2 Percentage of Participants
MaleClinical Type of Atrial Fibrillation at Baseline (Admission)Unknown3.0 Percentage of Participants
FemaleClinical Type of Atrial Fibrillation at Baseline (Admission)Persistent27.6 Percentage of Participants
FemaleClinical Type of Atrial Fibrillation at Baseline (Admission)1st Detected Episode33.6 Percentage of Participants
FemaleClinical Type of Atrial Fibrillation at Baseline (Admission)Paroxysmal31.9 Percentage of Participants
FemaleClinical Type of Atrial Fibrillation at Baseline (Admission)Permanent3.6 Percentage of Participants
FemaleClinical Type of Atrial Fibrillation at Baseline (Admission)Unknown3.3 Percentage of Participants
TotalClinical Type of Atrial Fibrillation at Baseline (Admission)Unknown3.1 Percentage of Participants
TotalClinical Type of Atrial Fibrillation at Baseline (Admission)Permanent4.0 Percentage of Participants
TotalClinical Type of Atrial Fibrillation at Baseline (Admission)1st Detected Episode30.8 Percentage of Participants
TotalClinical Type of Atrial Fibrillation at Baseline (Admission)Persistent33.1 Percentage of Participants
TotalClinical Type of Atrial Fibrillation at Baseline (Admission)Paroxysmal28.9 Percentage of Participants
Primary

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

Time frame: Baseline (time of admission)

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

ArmMeasureGroupValue (NUMBER)
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Obstructive Pulmonary Disease7.8 Percentage of Participants
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Peripheral Vascular Disease6.3 Percentage of Participants
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Renal Failure6.7 Percentage of Participants
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Anemia3.6 Percentage of Participants
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sleep Apnea Syndrome4.8 Percentage of Participants
MaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Haemorrhagic Complication1.2 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Haemorrhagic Complication1.8 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Obstructive Pulmonary Disease7.1 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Anemia5.3 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sleep Apnea Syndrome2.1 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Peripheral Vascular Disease5.1 Percentage of Participants
FemaleCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Renal Failure5.3 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Peripheral Vascular Disease5.8 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Renal Failure6.2 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Haemorrhagic Complication1.4 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Anemia4.2 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Chronic Obstructive Pulmonary Disease7.5 Percentage of Participants
TotalCo-Morbidity in Participants Presenting With Atrial Fibrillation at Baseline (Admission)Sleep Apnea Syndrome3.8 Percentage of Participants
Primary

Complications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial Fibrillation

Time frame: up to 60 days from day of treatment (cardioversion)

Population: All enrolled participants with follow-up data available

ArmMeasureGroupValue (NUMBER)
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationDeath198 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTorsade de pointes0 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMinor Bleeding12 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHypotension4 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSick Sinus syndrome1 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Fibrillation107 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPeripheral Embolism0 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationVentricular Fibrillation2 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Flutter10 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationNon-haemorrhagic Stroke7 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSymptomatic Ventricular Tachycardia0 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationAsystole for more than 3 seconds2 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationBradycardia4 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPulmonary Embolism1 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMyocardial Infarction2 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTamponade1 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTransient Ischaemic Attack0 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationOther Complication27 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationEndocarditis0 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHeart Failure9 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHaemorrhagic Stroke1 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSyncope5 Participants
MaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMajor Bleeding3 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMinor Bleeding6 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMyocardial Infarction2 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationNon-haemorrhagic Stroke3 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHaemorrhagic Stroke0 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPeripheral Embolism2 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPulmonary Embolism3 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTransient Ischaemic Attack1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHeart Failure10 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMajor Bleeding3 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationBradycardia0 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Fibrillation63 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Flutter2 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationAsystole for more than 3 seconds2 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSymptomatic Ventricular Tachycardia1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationVentricular Fibrillation1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSick Sinus syndrome2 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTorsade de pointes1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSyncope4 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationEndocarditis1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTamponade0 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHypotension1 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationOther Complication18 Participants
FemaleComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationDeath113 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMajor Bleeding6 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHypotension5 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTorsade de pointes1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHeart Failure19 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationNon-haemorrhagic Stroke10 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSyncope9 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTransient Ischaemic Attack1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationDeath311 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationEndocarditis1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPulmonary Embolism4 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationOther Complication45 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationTamponade1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationPeripheral Embolism2 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationAsystole for more than 3 seconds4 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Flutter12 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationBradycardia4 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSymptomatic Ventricular Tachycardia1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationRecurrence of Atrial Fibrillation170 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationHaemorrhagic Stroke1 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationVentricular Fibrillation3 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMinor Bleeding18 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationMyocardial Infarction4 Participants
TotalComplications Experienced by Participants Who Underwent a Cardioversion for Treatment of Atrial FibrillationSick Sinus syndrome3 Participants
Primary

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.

Time frame: At time of treatment (up to 1 day from admission)

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

ArmMeasureGroupValue (NUMBER)
MalePercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionElectrical Cardioversion69.5 Percentage of Participants
MalePercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionPharmacological Cardioversion30.5 Percentage of Participants
FemalePercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionElectrical Cardioversion55.1 Percentage of Participants
FemalePercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionPharmacological Cardioversion44.9 Percentage of Participants
TotalPercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionElectrical Cardioversion64.2 Percentage of Participants
TotalPercentage of Participants Who Had a Successful Electrical or Pharmacological CardioversionPharmacological Cardioversion35.8 Percentage of Participants
Primary

Treatments Utilized for Participants for Atrial Fibrillation

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
MaleTreatments Utilized for Participants for Atrial FibrillationPharmacological Cardioversion705 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationCatheter Ablation92 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationPacemaker20 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationImplantable Cardiac Defibrillator10 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationSurgical Therapy1 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationNo Treatment550 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationRate Control Change215 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationElectrical Cardioversion1677 Participants
MaleTreatments Utilized for Participants for Atrial FibrillationCombined Electrical/Pharmacological Cardioversion120 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationElectrical Cardioversion792 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationPharmacological Cardioversion609 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationCatheter Ablation32 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationCombined Electrical/Pharmacological Cardioversion69 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationRate Control Change152 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationImplantable Cardiac Defibrillator0 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationPacemaker18 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationNo Treatment342 Participants
FemaleTreatments Utilized for Participants for Atrial FibrillationSurgical Therapy0 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationPacemaker38 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationRate Control Change367 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationCatheter Ablation124 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationSurgical Therapy1 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationImplantable Cardiac Defibrillator10 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationNo Treatment892 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationElectrical Cardioversion2469 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationPharmacological Cardioversion1314 Participants
TotalTreatments Utilized for Participants for Atrial FibrillationCombined Electrical/Pharmacological Cardioversion189 Participants

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026