Trial · NCT02132767
Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
NCT02132767, Phase 3, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2017-01-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation. Trials, record NCT02132767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02132767
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rate Control Versus Rhythm Control For Postoperative Atrial Fibrillation
- NCT number
- NCT02132767
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 523 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Postoperative Atrial Fibrillation
- Interventions
- Amiodarone, DC-cardioversion, Rate Control
- First posted
- 2014-05-07
- Last updated
- 2019-03-15
- Results first posted
- 2017-01-18
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Days in Hospital | Within 60 days of randomization | The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy. |
| Secondary | Time to Conversion to Sustained, Stable Non-AF Rhythm | Up to index hospital discharge or 7 days post surgery, whichever came first | |
| Secondary | Heart Rhythm Comparison | Hospital discharge | Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge |
| Secondary | Heart Rhythm Comparison | 30 days after randomization | Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization |
| Secondary | Heart Rhythm Comparison | 60 days after randomization | Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization |
| Secondary | Length of Stay (Index Hospitalization) | Within 60 days post surgery | Overall length of stay for the index hospitalization |
| Secondary | Length of Stay (Rehospitalization, Including ED Visits) | Within 60 days of randomization | Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits |
| Secondary | Outpatient Interventions | Within 60 days of randomization | Compare frequency of outpatient visits between groups for any cause and AF-related causes |
| Secondary | AF- or Treatment-related Events | Within 60 days of randomization | |
| Secondary | Cost (Hospital) | Within 60 days of randomization | Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Days in Hospital | Within 60 days of randomization | All randomized patients (intent to treat) | days | MEDIAN |
| SECONDARY | Time to Conversion to Sustained, Stable Non-AF Rhythm | Up to index hospital discharge or 7 days post surgery, whichever came first | All randomized patients (intent to treat) | days | MEDIAN |
| SECONDARY | Heart Rhythm Comparison | Hospital discharge | participants | NUMBER | |
| SECONDARY | Heart Rhythm Comparison | 30 days after randomization | participants | NUMBER | |
| SECONDARY | Heart Rhythm Comparison | 60 days after randomization | participants | NUMBER | |
| SECONDARY | Length of Stay (Index Hospitalization) | Within 60 days post surgery | days | MEDIAN | |
| SECONDARY | Length of Stay (Rehospitalization, Including ED Visits) | Within 60 days of randomization | days | MEDIAN | |
| SECONDARY | Outpatient Interventions | Within 60 days of randomization | hospital stays < 24 hours | NUMBER | |
| SECONDARY | AF- or Treatment-related Events | Within 60 days of randomization | |||
| SECONDARY | Cost (Hospital) | Within 60 days of randomization |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Days in Hospital | Rate Control | 5.1 | Inter-Quartile Range 3.0 to 7.4 | days | |
| Total Number of Days in Hospital | Rhythm Control | 5.0 | Inter-Quartile Range 3.2 to 7.5 | days | |
| Time to Conversion to Sustained, Stable Non-AF Rhythm | Rate Control | 1.85 | Inter-Quartile Range 0.46 to 4.81 | days | |
| Time to Conversion to Sustained, Stable Non-AF Rhythm | Rhythm Control | 0.95 | Inter-Quartile Range 0.27 to 3.21 | days | |
| Heart Rhythm Comparison | Rate Control | 231 | participants | ||
| Heart Rhythm Comparison | Rhythm Control | 244 | participants | ||
| Heart Rhythm Comparison | Rate Control | 220 | participants | ||
| Heart Rhythm Comparison | Rhythm Control | 223 | participants | ||
| Heart Rhythm Comparison | Rate Control | 220 | participants | ||
| Heart Rhythm Comparison | Rhythm Control | 231 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rate Control | 262 | |
| Overall Study | STARTED | Rhythm Control | 261 | |
| Overall Study | COMPLETED | Rate Control | 245 | |
| Overall Study | COMPLETED | Rhythm Control | 246 | |
| Overall Study | NOT COMPLETED | Rate Control | 17 | |
| Overall Study | NOT COMPLETED | Rhythm Control | 15 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bleeding | General disorders | Rate Control | 2 | 262 | 2 |
| other | Bleeding | General disorders | Rhythm Control | 1 | 261 | 2 |
| other | Cardiac Arrhythmias | Cardiac disorders | Rate Control | 2 | 262 | 2 |
| other | Cardiac Arrhythmias | Cardiac disorders | Rhythm Control | 7 | 261 | 8 |
| other | Major infection | Infections and infestations | Rate Control | 17 | 262 | 18 |
| other | Major infection | Infections and infestations | Rhythm Control | 11 | 261 | 11 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Rate Control | 5 | 262 | 5 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Rhythm Control | 1 | 261 | 1 |
| other | Renal events | Renal and urinary disorders | Rate Control | 3 | 262 | 4 |
| other | Renal events | Renal and urinary disorders | Rhythm Control | 6 | 261 | 6 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rate Control | ||
| Total, all-cause mortality | Rhythm Control | ||
| Total, other adverse events | Rate Control | 29 | 262 |
| Total, other adverse events | Rhythm Control | 26 | 261 |
| Total, serious adverse events | Rate Control | 71 | 262 |
| Total, serious adverse events | Rhythm Control | 73 | 261 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL088942 | Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine | GELIJNS, ANNE CHRISTINE; MOSKOWITZ, ALAN J | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2007 to 2025 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rate Control vs Rhythm Control: Heart Rhythm Comparison | Trial comparisons |
| Rate Control vs Rhythm Control: Heart Rhythm Comparison | Trial comparisons |
| Rate Control vs Rhythm Control: Heart Rhythm Comparison | Trial comparisons |
| Rate Control vs Rhythm Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02132767
GET https://conductscience.org/api/trials/v1/NCT02132767/events?page=2