NCT00469638

Brief Summary

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2007

Typical duration for not_applicable atrial-fibrillation

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

May 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

May 3, 2007

Last Update Submit

February 1, 2019

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationparoxysmalpersistentsymptomaticablationcatheterintroducerAgilis NxTsinus rhythmparoxysmal atrial fibrillationpersistent atrial fibrillationsymptomatic atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)

    6 months post ablation

Secondary Outcomes (1)

  • rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration

    6 month post ablation

Study Arms (2)

Agilis sheeth group

EXPERIMENTAL
Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth

Non-steerable sheeth group

ACTIVE COMPARATOR
Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Interventions

Left atrial catheter ablation guided by introducer using Agilis sheethPROCEDURE

Left atrial catheter ablation guided by introducer using Agilis sheeth

Agilis sheeth group
Left atrial catheter ablation guided by introducer using Non-steerable sheethPROCEDURE

Left atrial catheter ablation guided by introducer using Non-steerable sheeth

Non-steerable sheeth group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Paroxysmal or persistent symptomatic atrial fibrillation
  • Resistant to at least 1 anti arrhythmic drug
  • Left atrial diameter less then 60 mm (TTE, parasternal)
  • Atrial fibrillation documented by ECG
  • Patient is willing and available to perform all Follow Ups

You may not qualify if:

  • Permanent atrial fibrillation
  • Pre existing left atrial fibrillation ablation
  • Atrial fibrillation due to reversible cause
  • Known intracardiac or other thrombi
  • Pregnancy
  • Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
  • Contraindication for anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herzzenturm Leipzig

Leipzig, 04289, Germany

Location

Related Publications (4)

  • Kannel WB, Abbott RD, Savage DD, McNamara PM. Epidemiologic features of chronic atrial fibrillation: the Framingham study. N Engl J Med. 1982 Apr 29;306(17):1018-22. doi: 10.1056/NEJM198204293061703.

    PMID: 7062992BACKGROUND

  • Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.

    PMID: 1866765BACKGROUND

  • Piorkowski C, Hindricks G, Weiss S et al: Long term outcome of circumferential left atrial PV ablation using a steerable transseptal sheath. Poster European Society of Cardiology 2006, Barcelona

    BACKGROUND

  • Piorkowski C, Eitel C, Rolf S, Bode K, Sommer P, Gaspar T, Kircher S, Wetzel U, Parwani AS, Boldt LH, Mende M, Bollmann A, Husser D, Dagres N, Esato M, Arya A, Haverkamp W, Hindricks G. Steerable versus nonsteerable sheath technology in atrial fibrillation ablation: a prospective, randomized study. Circ Arrhythm Electrophysiol. 2011 Apr;4(2):157-65. doi: 10.1161/CIRCEP.110.957761. Epub 2011 Jan 19.

    PMID: 21248246DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerhard Hindricks, Prof. Dr.

    Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

DE(1)