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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Fibrillation; Rate Control; Catheter Ablation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients coexisted with heart failure and atrial fibrillation

Description

Inclusion Criteria:

• age>18 years
• documented atrial fibrillation
• New York Heart Association Ⅱ-Ⅳ or left ventricular ejection fraction <50%

Exclusion Criteria:

• heart failure that had a suspected reversible cause
• previous ablation
• any contraindication to catheter ablation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
catheter ablation group; atrial fibrillation patients with heart failure who received catheter ablation for rhythm control
rate control group; atrial fibrillation patients with heart failure who received pharmacological approaches for rate control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality		up to 3 years
stroke	stroke must be certified by CT scan	up to 3 years
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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Investigators: Principal Investigator: Jin Geng, MD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Study Chair: Bingjian Wang, MD, Huai'an First People's Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimated): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: 20160020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No