NCT00750711

Brief Summary

The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter study.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 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

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

September 16, 2008

Status Verified

September 1, 2008

Enrollment Period

1.8 years

First QC Date

September 9, 2008

Last Update Submit

September 15, 2008

Conditions

Typical Atrial FlutterRadiofrequency AblationIrrigated Catheters

Outcome Measures

Primary Outcomes (1)

  • Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months

    6 months

Study Arms (1)

KT,2

EXPERIMENTAL

There are two arms in this study: KT2 arm and KT4 arm. Patients in KT2 arm will be ablated with the 2 mm irrigated catheter and patients in KT4 mm will be ablated with the 4 mm irrigated catheter.

Procedure: Radiofrequency ablation for atrial flutter by catheters

Interventions

Radiofrequency ablation for atrial flutter by cathetersPROCEDURE
KT,2

Eligibility Criteria

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

You may qualify if:

  • All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter

You may not qualify if:

  • Pregnancy
  • Hemodynamic instability
  • A recurrence of previous ablated typical atrial flutter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

University Hospital of Geneva

Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Dipen DS Shah, professor

CONTACT

0041223727197dipen.shah@hcuge.ch

Henri HS Sunthorn, doctor

CONTACT

0041223727194henri.sunthorn@hcuge.ch

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

September 9, 2008

First Posted

September 10, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Last Updated

September 16, 2008

Record last verified: 2008-09

Locations

CH(2)