NCT03634592

Brief Summary

This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 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

August 2, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

August 2, 2018

Last Update Submit

March 4, 2024

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Freedom from atrial fibrillation

    Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms.

    1 year

Secondary Outcomes (4)

  • Acute complications

    30 days

  • Procedure time

    180 minutes

  • Fluoroscopy time

    24 hours

  • Electrical reconduction

    2 years

Interventions

Catheter ablationPROCEDURE

Radiofrequency catheter pulmonary vein isolation

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (both males and females aged 18-79 years) with indications to atrial fibrillation ablation undergoing radiofrequency catheter pulmonary vein isolation

You may qualify if:

  • indications for catheter ablation of atrial fibrillation;
  • signed informed consent

You may not qualify if:

  • Presence of contraindications to AF ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 16, 2018

Study Start

October 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

RU(1)