Trial · NCT07272902
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Trial Conduct | 12 months after randomization | Recruitment rate (patients recruited per center per month) and crossover rate (percentage of participants switching study arms). Feasibility will be defined as ≥0.7 patients enrolled per center per month and ≤10% crossover. |
| Secondary | Composite of Cardiovascular Mortality and Heart Failure Hospitalization | Up to 12 months post-randomization | Time to first event of cardiovascular death (due to MI, sudden cardiac death, HF, stroke, CV procedures, CV bleeding, or other CV cause) or hospitalization for heart failure (admission \>24h, ED visit, or unscheduled IV diuretic administration). |
| Secondary | All-Cause Mortality | Up to 12 months | Death from any cause |
| Secondary | Cardiovascular Hospitalizations and ED Visits (Non-HF) | Up to 12 months | Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation. |
| Secondary | Quality of Life: EQ-5D (Euroquol 5D Questionnaire) | Baseline, 12 months | EQ5D Will include responses from the Euroquol 5D questionnaire |
| Secondary | Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire | Baseline, 12 months | AFEQT- Atrial Fibrillation Effect on Quality of Life Questionnaire (Scored 0-100, 0 is complete disability, 100 is no disability) |
| Secondary | Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12) | Baseline, 12 months | KCCQ-12- Kansas City Cardiomyopathy Questionnaire-12 (0-100, 0 is very poor, 100 is excellent) |
| Secondary | Atrial Fibrillation Burden | Baseline, 3, 6, and 12 months | Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings |
| Secondary | Change in NT-proBNP levels | Baseline, 12 months | Change in plasma NT-proBNP levels from baseline to follow-up |
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | Baseline, 12 months | Change in LVEF as measured by echocardiography |
| Secondary | Exercise Capacity (6-Minute Walk Distance) | Baseline, 12 months | Change in distance walked in 6 minutes from baseline to follow-up |
| Secondary | Recruitment Metrics | Throughout 12-month recruitment | Recruitment ration of male vs. female participants, refusal rates and reasons. |
| Other | Procedural Complications | Up to 30 days post-ablation procedure | Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring transfusion. |
| Other | Antiarrhythmic Drug Adverse Events | Up to 12 months | Incidence of drug-related toxicities (e.g., thyroid, hepatic, pulmonary, proarrhythmia) |
| Other | All-Cause Death | Up to 12 months | Number of deaths from any cause |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07272902/registered