NCT01229306

Brief Summary

Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

3 years

First QC Date

October 26, 2010

Last Update Submit

May 2, 2013

Conditions

AblationParoxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Freedom of atrial arrhythmias

Secondary Outcomes (1)

  • Quality of life, number of reconnected pulmonary veins, safety

Study Arms (2)

reisolation of all PV and additional anterior line

EXPERIMENTAL
Procedure: Ablation

reisolation of all pulmonary veins

PLACEBO COMPARATOR
Procedure: Ablation

Interventions

AblationPROCEDURE

Ablation of atrial fibrillation

reisolation of all PV and additional anterior linereisolation of all pulmonary veins

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • relapse of atrial fibrillation

You may not qualify if:

  • contraindication for ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum

München, Bayer, 80636, Germany

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2010

First Posted

October 27, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

January 1, 2014

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

DE(1)