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NCT02846922 Clinical Trial

Catheter Ablation and Rate Control of Atrial Fibrillation in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:
Catheter Ablation Versus Rate Control in Patients With Atrial Fibrillation and Heart Failure: A Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date July 2023
Source Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the efficacy of catheter ablation and rate control in heart failure patients with atrial fibrillation.

Description:

All patients received either catheter ablation for rhythm control or rate control before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Drum Tower Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
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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