NCT02846922

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 25, 2016

Last Update Submit

July 11, 2023

Conditions

Catheter AblationRate ControlHeart FailureAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    composite of all-cause mortality, stroke and unplanned hospitalization due to cardiovascular reasons

    up to 3 years

Secondary Outcomes (3)

  • all-cause mortality

    up to 3 years

  • stroke

    up to 3 years

  • unplanned hospitalization due to cardiovascular reasons

    up to 3 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients coexisted with heart failure and atrial fibrillation

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Heart FailureAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jin Geng, MD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

  • Bingjian Wang, MD

    Huai'an First People's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)