Atrial FlutterPhase 4NCT00196170
Randomized Study of Radiofrequency- vs. Cryo-Ablation for Typical Isthmus-Dependent Atrial Flutter
A Phase 4 study testing RF ablation of the cavo-tricuspid isthmus, cryo ablation of the cavo-tricuspid isthmus and irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus in people with Atrial Flutter, run by Deutsches Herzzentrum Muenchen at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Flutter
- What is being tested?
- RF ablation of the cavo-tricuspid isthmus, cryo ablation of the cavo-tricuspid isthmus and irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- May 2003to Jul 2008
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years
- documented atrial flutter which is most probably typical isthmus dependent atrial flutter
- informed written consent
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Deutsches Herzzentrum Muenchen
Munich, 80636
Westfälische Wilhelms-Universitaet Muenster
Münster, 48149
Klinikum Nuernberg Sued
Nuremberg, 90471
About this study
Official title: Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
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.
Read the detailed description
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. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.
The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.
- Conditions
- Atrial Flutter
- Being tested
- RF ablation of the cavo-tricuspid isthmus, cryo ablation of the cavo-tricuspid isthmus, irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus, cryo 6.5mm tip ablation of the cavotricuspid isthmus
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF ablation of the cavo-tricuspid isthmusProcedure or surgery
8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
cryo ablation of the cavo-tricuspid isthmusProcedure or surgery
Cryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
irrigated tip radiofrequency ablation of the cavo-tricuspid isthmusProcedure or surgery
irrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter
cryo 6.5mm tip ablation of the cavotricuspid isthmusProcedure or surgery
cryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 8mm tip ablation catheter for ablation of cavotricuspid isthmus Receives: Procedure: RF ablation of the cavo-tricuspid isthmus |
| 2 | Experimental | irrigated tip ablation catheter for ablation of cavotricuspid isthmus Receives: Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus |
| 3 | Experimental | cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus Receives: Procedure: cryo ablation of the cavo-tricuspid isthmus |
| 4 | Experimental | Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus Receives: Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Efficacy (bidirectional cavotricuspid isthmus block)
Measured: bidirectional cavotricuspid isthmus block
Long-term efficacy (6 months FU freedom of typical atrial flutter)
Measured: 6 months
Mortality
Measured: 6 months
Secondary outcomes (2)
Patients' pain scores during ablation
Measured: while hospitalisation
Safety of ablational devices
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 posted20 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionApr 2008 (estimated)
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Investigators
- Claus Schmitt, MD, Study chair, Deutsches Herzzentrum MuenchenBernhard Zrenner, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196170
- Sponsor's protocol ID
- GE IDE No. C00303
- Status last verified
- Mar 2008
- First submitted
- 12 Sep 2005
- Last updated
- 19 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
- ClinicalTrials.gov ID
- NCT00196170
- Acronym / sponsor ID
- GE IDE No. C00303
- Conditions
- Atrial Flutter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- May 2003
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 20 Sep 2005 (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.
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.
Detailed description
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. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.
The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: RF ablation of the cavo-tricuspid isthmus8mm tip ablation catheter for ablation of cavotricuspid isthmus |
| 2 | Experimental | Procedure: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmusirrigated tip ablation catheter for ablation of cavotricuspid isthmus |
| 3 | Experimental | Procedure: cryo ablation of the cavo-tricuspid isthmuscryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus |
| 4 | Experimental | Procedure: cryo 6.5mm tip ablation of the cavotricuspid isthmusCryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 80 years
- documented atrial flutter which is most probably typical isthmus dependent atrial flutter
- informed written consent
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| RF ablation of the cavo-tricuspid isthmus8mm tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter | Procedure or surgery | 1 |
| cryo ablation of the cavo-tricuspid isthmusCryo 10mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter | Procedure or surgery | 3 |
| irrigated tip radiofrequency ablation of the cavo-tricuspid isthmusirrigated tip ablation catheter is used for the radiofrequency ablation of the cavo-tricuspid isthmus in typical atrial flutter | Procedure or surgery | 2 |
| cryo 6.5mm tip ablation of the cavotricuspid isthmuscryo 6.5mm tip ablation catheter is used for the cryo ablation of the cavo-tricuspid isthmus in typical atrial flutter | Procedure or surgery | 4 |
Primary outcome
Acute Efficacy (bidirectional cavotricuspid isthmus block)
Time frame: bidirectional cavotricuspid isthmus block
Long-term efficacy (6 months FU freedom of typical atrial flutter)
Time frame: 6 months
Mortality
Time frame: 6 months
2 secondary outcomes
Patients' pain scores during ablation
Time frame: while hospitalisation
Safety of ablational devices
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 19 Mar 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.
Claus Schmitt, MD study chair
Deutsches Herzzentrum Muenchen
Bernhard Zrenner, MD principal investigator
Deutsches Herzzentrum Muenchen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RF ablation of the cavo-tricuspid isthmus, cryo ablation of the cavo-tricuspid isthmus and irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus in people with Atrial Flutter, run by Deutsches Herzzentrum Muenchen at 4 sites in Germany.
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 3 inclusion and 8 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 19 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Efficacy (bidirectional cavotricuspid isthmus block) (time frame: bidirectional cavotricuspid isthmus block). The study lists 3 primary outcomes in all. 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 19 Mar 2008.