Typical Atrial FlutterNCT00750711
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
A study testing Radiofrequency ablation for atrial flutter by catheters in people with Typical Atrial Flutter and Radiofrequency Ablation, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Typical Atrial Flutter, Radiofrequency Ablation, Irrigated Catheters
- What is being tested?
- Radiofrequency ablation for atrial flutter by catheters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter
Who cannot join
- Pregnancy
- Hemodynamic instability
- A recurrence of previous ablated typical atrial flutter
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital of Geneva
Geneva, Canton of Geneva, 1211
Dipen DS Shah, professor, 0041223727197, dipen.shah@hcuge.ch
Henri HS Sunthorn, doctor, 0041223727194, henri.sunthorn@hcuge.ch
- Recruiting
University Hospital of Geneva
Geneva, 1211
Dipen DS Shah, professor, 0041223727197, dipen.shah@hcuge.ch
Henri SH Sunthorn, doctor
About this study
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.
- Being tested
- Radiofrequency ablation for atrial flutter by catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation for atrial flutter by cathetersProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Radiofrequency ablation for atrial flutter by catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typical Atrial FlutterStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750711
- Sponsor's protocol ID
- Protocole 08-006
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
- ClinicalTrials.gov ID
- NCT00750711
- Acronym / sponsor ID
- Protocole 08-006
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KT,2 | Experimental | Procedure: Radiofrequency ablation for atrial flutter by cathetersThere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter
Key exclusion criteria (3 listed)
- Pregnancy
- Hemodynamic instability
- A recurrence of previous ablated typical atrial flutter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation for atrial flutter by catheters | Procedure or surgery | KT,2 |
Primary outcome
Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation for atrial flutter by catheters in people with Typical Atrial Flutter and Radiofrequency Ablation, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dipen DS Shah, professor (0041223727197, dipen.shah@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2008.