NCT00605748

Brief Summary

We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)

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
212

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4 atrial-fibrillation

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

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

1.5 years

First QC Date

January 18, 2008

Last Update Submit

August 26, 2008

Conditions

Atrial Fibrillation

Keywords

catheter ablationatrial fibrillationpulmonary vein

Outcome Measures

Primary Outcomes (1)

  • freedom of atrial tachycardia 6 months after ablation

    6 months

Secondary Outcomes (1)

  • freedom of symptoms due to atrial tachycardia 6 months after ablation safety

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Segmental PV-Isolation of the arrhythmogenic vein(s)

Procedure: Segmental PV-Isolation of the arrhythmogenic vein(s)

2

ACTIVE COMPARATOR

Segmental PV-Isolation of all veins

Procedure: Segmental PV-Isolation of all veins

Interventions

Segmental PV-Isolation of the arrhythmogenic vein(s)PROCEDURE

isolation of pulmonary veins for curing atrial fibrillation

1
Segmental PV-Isolation of all veinsPROCEDURE

isolation of pulmonary veins for curing atrial fibrillation

2

Eligibility Criteria

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

You may qualify if:

  • patients between 18 and 80 years old with paroxysmal atrial fibrillation
  • Episodes with a maximum duration for 7 days
  • at least 4 episodes / month
  • at least one attempt with Class I or III anti-arrhythmic drugs and/or with ß-blockers without success
  • sufficient oral anticoagulation for a minimum of four weeks previous to ablation

You may not qualify if:

  • hyperthyroidism
  • mitral regurgitation \> II°
  • intracardiac thrombi documented by transesophageal echocardiography
  • left ventricular ejection\< fraction 35%,
  • history of ablation, myocardial infarction or cardiac surgery in the previous 3 months
  • history of left-atrial ablation procedure
  • contraindication for oral anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

RECRUITING

Related Publications (1)

  • Fichtner S, Hessling G, Ammar S, Reents T, Estner HL, Jilek C, Kathan S, Buchner M, Dillier R, Deisenhofer I. A prospective randomized study comparing isolation of the arrhythmogenic vein versus all veins in paroxysmal atrial fibrillation. Clin Cardiol. 2013 Jul;36(7):422-6. doi: 10.1002/clc.22132. Epub 2013 May 13.

    PMID: 23670880DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabel Deisenhofer, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Heidi L. Estner, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi L. Estner, MD

CONTACT

+49 89 1218estner@dhm.mhn.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations

DE(1)