Heart Failure Clinical Trial
Official title:
Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study
NCT number | NCT02846922 |
Other study ID # | 20160020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | December 2016 |
Verified date | July 2023 |
Source | Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.
Status | Completed |
Enrollment | 394 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age>18 years - documented atrial fibrillation - New York Heart Association ?-? or left ventricular ejection fraction <50% Exclusion Criteria: - heart failure that had a suspected reversible cause - previous ablation - any contraindication to catheter ablation |
Country | Name | City | State |
---|---|---|---|
China | Drum Tower Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major adverse cardiac events | composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons | up to 3 years | |
Secondary | all-cause mortality | up to 3 years | ||
Secondary | stroke | stroke must be certified by CT scan | up to 3 years | |
Secondary | unplanned hospitalization due to cardiovascular reasons | Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of heart failure and ventricular arrhythmias | up to 3 years |
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