Trial · NCT00911508
Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
NCT00911508, Not applicable, Completed, Mayo Clinic; results first posted 2019-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial. Trials, record NCT00911508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00911508
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial
- NCT number
- NCT00911508
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,204 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Atrial Fibrillation, Arrhythmia
- Interventions
- Left atrial ablation, Rate or Rhythm Control Therapy
- First posted
- 2009-06-02
- Last updated
- 2021-04-21
- Results first posted
- 2019-08-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. | From date of enrollment until time-to-first event over a median follow-up of 48.5 months. | All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of ≥3 units of blood. |
| Secondary | Number of Participants With All-cause Mortality | From date of enrollment until date of death over a median follow-up of 48.5 months. | All deaths were reviewed and adjudicated by the Clinical Events Committee |
| Secondary | Number of Participants With Mortality or Cardiovascular (CV) Hospitalization | From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months. | Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form. |
| Secondary | Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) | From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months. | Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2 and the reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form. |
| Secondary | Number of Participants With Cardiovascular Death | From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months. | Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator |
| Secondary | Number of Participants With Cardiovascular Death or Disabling Stroke | From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months. | Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2. |
| Secondary | Number of Participants With an Arrhythmic Death or Cardiac Arrest | From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months. | All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee |
| Secondary | Number of Participants With Heart Failure Death | From date of enrollment until date of heart failure death over a median follow-up of 48.5 months. | All deaths were categorized and adjudicated by the Clinical Events Committee |
| Secondary | Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period | From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months. | Data from patients using the study provided ECG event recording system were analyzed. A 30-second episode of AF in either group, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF. |
| Secondary | Number of Participants With Cardiovascular Hospitalization | From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months. | The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. | From date of enrollment until time-to-first event over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With All-cause Mortality | From date of enrollment until date of death over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Mortality or Cardiovascular (CV) Hospitalization | From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) | From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cardiovascular Death | From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Cardiovascular Death or Disabling Stroke | From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Arrhythmic Death or Cardiac Arrest | From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Heart Failure Death | From date of enrollment until date of heart failure death over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period | From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months. | Subjects were analyzed in the post-blanking period if randomized treatment occurred and the subject did not die, withdraw, or get lost to follow-up before the end of the 90 day blanking period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cardiovascular Hospitalization | From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. | Left Atrial Ablation | 89 | Participants | ||
| Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. | Rate or Rhythm Control Therapy | 101 | Participants | ||
| Number of Participants With All-cause Mortality | Left Atrial Ablation | 58 | Participants | ||
| Number of Participants With All-cause Mortality | Rate or Rhythm Control Therapy | 67 | Participants | ||
| Number of Participants With Mortality or Cardiovascular (CV) Hospitalization | Left Atrial Ablation | 573 | Participants | ||
| Number of Participants With Mortality or Cardiovascular (CV) Hospitalization | Rate or Rhythm Control Therapy | 637 | Participants | ||
| Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) | Left Atrial Ablation | 170 | Participants | ||
| Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) | Rate or Rhythm Control Therapy | 189 | Participants | ||
| Number of Participants With Cardiovascular Death | Left Atrial Ablation | 22 | Participants | ||
| Number of Participants With Cardiovascular Death | Rate or Rhythm Control Therapy | 23 | Participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Left Atrial Ablation | 1,108 | |
| Overall Study | STARTED | Rate or Rhythm Control Therapy | 1,096 | |
| Overall Study | COMPLETED | Left Atrial Ablation | 1,002 | |
| Overall Study | COMPLETED | Rate or Rhythm Control Therapy | 966 | |
| Overall Study | NOT COMPLETED | Left Atrial Ablation | 106 | |
| Overall Study | NOT COMPLETED | Rate or Rhythm Control Therapy | 130 |
Source ClinicalTrials.gov
Adverse events982
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 |
|---|---|---|---|---|---|---|
| serious | ANAEMIA | Blood and lymphatic system disorders | Left Atrial Ablation | 1 | 1,108 | 1 |
| serious | ANAEMIA | Blood and lymphatic system disorders | Rate or Rhythm Control Therapy | 5 | 1,096 | 5 |
| serious | ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | Left Atrial Ablation | 0 | 1,108 | 0 |
| serious | ANAEMIA OF MALIGNANT DISEASE | Blood and lymphatic system disorders | Rate or Rhythm Control Therapy | 1 | 1,096 | 1 |
| serious | AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | Left Atrial Ablation | 1 | 1,108 | 1 |
| serious | AUTOIMMUNE HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | Rate or Rhythm Control Therapy | 0 | 1,096 | 0 |
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Left Atrial Ablation | 0 | 1,108 | 0 |
| serious | FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | Rate or Rhythm Control Therapy | 1 | 1,096 | 1 |
| serious | HAEMORRHAGIC DISORDER | Blood and lymphatic system disorders | Left Atrial Ablation | 1 | 1,108 | 1 |
| serious | HAEMORRHAGIC DISORDER | Blood and lymphatic system disorders | Rate or Rhythm Control Therapy | 0 | 1,096 | 0 |
1 to 10 of 982Source ClinicalTrials.gov
See all 982 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Left Atrial Ablation | 58 | 1,108 |
| Total, all-cause mortality | Rate or Rhythm Control Therapy | 67 | 1,096 |
| Total, other adverse events | Left Atrial Ablation | 0 | 1,108 |
| Total, other adverse events | Rate or Rhythm Control Therapy | 0 | 1,096 |
| Total, serious adverse events | Left Atrial Ablation | 454 | 1,108 |
| Total, serious adverse events | Rate or Rhythm Control Therapy | 430 | 1,096 |
Source ClinicalTrials.gov
Papers19
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 |
|---|---|---|---|---|---|
| U01HL089709 | Catheter Ablation versus Antiarrythmic Drug Therapy for Atrial Fibrilllation Tria | PACKER, DOUGLAS L | MAYO CLINIC ROCHESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2009 to 2014 |
Source NIH RePORTER
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Heart Failure Death | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events) | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Mortality or Cardiovascular (CV) Hospitalization | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With an Arrhythmic Death or Cardiac Arrest | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With All-cause Mortality | Trial comparisons |
Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF. | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Cardiovascular Death | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: Number of Participants With Cardiovascular Hospitalization | Trial comparisons |
| Left Atrial Ablation vs Rate or Rhythm Control Therapy: deaths from any cause | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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.
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Read this trial from software.
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