- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750711
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
September 15, 2008 updated by: University Hospital, Geneva
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dipen DS Shah, professor
- Phone Number: 0041223727197
- Email: dipen.shah@hcuge.ch
Study Contact Backup
- Name: Henri HS Sunthorn, doctor
- Phone Number: 0041223727194
- Email: henri.sunthorn@hcuge.ch
Study Locations
-
-
-
Geneva, Switzerland, 1211
- Recruiting
- University Hospital of Geneva
-
Contact:
- Dipen DS Shah, professor
- Phone Number: 0041223727197
- Email: dipen.shah@hcuge.ch
-
Contact:
- Henri HS Sunthorn, doctor
- Phone Number: 0041223727194
- Email: henri.sunthorn@hcuge.ch
-
Principal Investigator:
- Henri SH Sunthorn, doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter
Exclusion Criteria:
- Pregnancy
- Hemodynamic instability
- A recurrence of previous ablated typical atrial flutter
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: KT,2
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Anticipated)
January 1, 2010
Study Registration Dates
First Submitted
September 9, 2008
First Submitted That Met QC Criteria
September 9, 2008
First Posted (Estimate)
September 10, 2008
Study Record Updates
Last Update Posted (Estimate)
September 16, 2008
Last Update Submitted That Met QC Criteria
September 15, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocole 08-006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiofrequency Ablation
-
National Taiwan University HospitalRecruitingRadiofrequency AblationTaiwan
-
Mayo ClinicCompletedRadiofrequency Ablation in Patients With Spinal HardwareUnited States
-
Capital Medical UniversityUnknown
-
Fayoum University HospitalCompletedRadiofrequency AblationEgypt
-
Second Affiliated Hospital, School of Medicine,...RecruitingImmunosuppression | Radiofrequency Ablation | Tumor ImmunityChina
-
China International Neuroscience InstitutionRecruitingEpilepsy | Radiofrequency AblationChina
-
Johns Hopkins UniversityTerminatedNeuritis | Radiofrequency AblationUnited States
-
Southwest Hospital, ChinaXijing Hospital; Xiangya Hospital of Central South University; Henan Cancer Hospital and other collaboratorsUnknownHCC | Radiofrequency Ablation | SorafenibChina
-
King Hamad University Hospital, BahrainCompletedRadiofrequency Ablation | Chronic Sacroiliac Joint ArthropathyBahrain
-
Ottawa Heart Institute Research CorporationUniversity of British Columbia; McGill UniversityNot yet recruitingAtrial Fibrillation | Radiofrequency Catheter Ablation | Catheter AblationCanada
Clinical Trials on Radiofrequency ablation for atrial flutter by catheters
-
University Hospital, RouenTerminated
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...TerminatedAtrial FlutterGermany
-
Biosense Webster, Inc.CompletedAtrial FlutterUnited States
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...TerminatedAtrial FlutterGermany
-
University Hospital, RouenMedtronicCompletedAtrial Fibrillation | Atrial FlutterFrance
-
Yonsei UniversityCompletedAtrial FibrillationKorea, Republic of
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...Completed
-
Stiftung Institut fuer HerzinfarktforschungBoston Scientific CorporationCompleted
-
EPD Solutions, A Philips CompanyTerminated
-
University of California, San DiegoCatheter Robotics, Inc.CompletedAtrial Fibrillation | Atrial FlutterUnited States