NCT00196170

Brief Summary

This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety.

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
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

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

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 19, 2008

Status Verified

March 1, 2008

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

March 18, 2008

Conditions

Atrial Flutter

Outcome Measures

Primary Outcomes (3)

  • Acute Efficacy (bidirectional cavotricuspid isthmus block)

    bidirectional cavotricuspid isthmus block

  • Long-term efficacy (6 months FU freedom of typical atrial flutter)

    6 months

  • Mortality

    6 months

Secondary Outcomes (2)

  • Patients' pain scores during ablation

    while hospitalisation

  • Safety of ablational devices

    6 months

Study Arms (4)

1

EXPERIMENTAL

8mm tip ablation catheter for ablation of cavotricuspid isthmus

Procedure: RF ablation of the cavo-tricuspid isthmus

2

EXPERIMENTAL

irrigated tip ablation catheter for ablation of cavotricuspid isthmus

Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus

3

EXPERIMENTAL

cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus

Procedure: cryo ablation of the cavo-tricuspid isthmus

4

EXPERIMENTAL

Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus

Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus

Interventions

RF ablation of the cavo-tricuspid isthmusPROCEDURE

8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter

1
cryo ablation of the cavo-tricuspid isthmusPROCEDURE

Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter

3
irrigated tip radiofrequency ablation of the cavo-tricuspid isthmusPROCEDURE

irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter

2
cryo 6.5mm tip ablation of the cavotricuspid isthmusPROCEDURE

cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter

4

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 80 years
  • documented atrial flutter which is most probably typical isthmus dependent atrial flutter
  • informed written consent

You may not qualify if:

  • prior ablation for atrial flutter
  • concomitant arrhythmia which is treated during the same ablation procedure
  • prior MAZE operation
  • contra indication for catheterization
  • physical or psychiatric disorder making participation in the study impossible
  • pregnancy
  • prior participation in the study
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Herz-Zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Westfälische Wilhelms-Universitaet Muenster

Münster, 48149, Germany

Location

Klinikum Nuernberg Sued

Nuremberg, 90471, Germany

Location

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claus Schmitt, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Bernhard Zrenner, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2003

Primary Completion

April 1, 2008

Study Completion

July 1, 2008

Last Updated

March 19, 2008

Record last verified: 2008-03

Locations

DE(4)