NCT02699255

Brief Summary

The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Typical duration 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

Study Start

First participant enrolled

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2017

Completed
Last Updated

June 7, 2019

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

February 23, 2016

Last Update Submit

June 6, 2019

Conditions

Ventricular ArrhythmiasAtrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Ventricular arrhythmias

    Number of patients with premature ventricular complexes, ventricular tachycardias or ventricular fibrillation.

    one year

Secondary Outcomes (1)

  • Arrhythmia recurrence

    one year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

You may qualify if:

  • Age \> 18 years
  • Paroxysmal atrial fibrillation scheduled to undergo pulmonary vein isolation

You may not qualify if:

  • Age \< 18 years
  • Persistent atrial fibrillation
  • Life expectancy less than 12 months
  • Documentation of \>30 premature ventricular complexes per hour, salvos or ventricular tachycardias prior to atrial fibrillation ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Meyer, Prof. Dr.

    Department of Cardiology - Electrophysiology, University Heart Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 4, 2016

Study Start

October 1, 2014

Primary Completion

January 27, 2017

Study Completion

January 27, 2017

Last Updated

June 7, 2019

Record last verified: 2018-10

Locations

DE(1)