NCT02654353

Brief Summary

This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_4

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

February 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

3.8 years

First QC Date

January 9, 2016

Last Update Submit

January 12, 2016

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent atrial fibrillation, catheter ablation, outcome

Outcome Measures

Primary Outcomes (1)

  • Number of patients without any arrhythmias during follow-up of 12 months

    12 months

Study Arms (2)

Group A: stepwise ablation

OTHER

Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach

Procedure: Ablation

Group B: sequential substrate ablation

ACTIVE COMPARATOR

Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation

Procedure: Ablation

Interventions

AblationPROCEDURE

In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.

Group A: stepwise ablationGroup B: sequential substrate ablation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • persistent atrial fibrillation lasting longer than 3 months
  • no previous ablations
  • at least 1 electrical cardioversion

You may not qualify if:

  • non-persistent atrial fibrillation
  • previous ablation procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Mainz, Department of Medicine II

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Rostock, MD

    University Hospital Mainz, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Thomas Rostock

Study Record Dates

First Submitted

January 9, 2016

First Posted

January 13, 2016

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

DE(1)