Trial · NCT00911508
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Changes in Quality of Life Measures - AFEQT | Baseline ,12 month, 5 years | Atrial Fibrillation Effect on Quality of Life (AFEQT) Overall Score (Scale: 0 = complete disability, 100 = no disability). The AFEQT is a 21-item AF-specific, health-related QOL questionnaire designed to assess the effect of atrial fibrillation on patient quality of life. The AFEQT has an Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Overall and subscale scores range from 0 (corresponds to complete disability) to 100 (no AF-related disability). |
| Secondary | Changes in Quality of Life Measures - MAFSI Frequency Score | Baseline, 12 Month, 5 Year | The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score). |
| Secondary | Changes in Quality of Life Measures - MAFSI Severity Score | Baseline, 12 Month, 5 Year | The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms). |
| Secondary | Number of Participants With Adverse Events/Complications | From treatment start date to date of event over a median follow-up of 48.5 months. | Comparing individual non-endpoint adverse events between ablative and drug therapy is difficult due to the substantial difference in the types of adverse events expected. Ablation-related events were counted among all patients that were randomized to and received an ablation. Drug-related events were counted among all patients that were randomized to and received drug therapy. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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