Atrioventricular Nodal Reentry TachycardiaPhase 4NCT00196222
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)
A Phase 4 study testing RF-ablation and cryo ablation in people with Atrioventricular Nodal Reentry Tachycardia, run by Deutsches Herzzentrum Muenchen at 10 sites in Germany.
Trial summary
In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrioventricular Nodal Reentry Tachycardia
- What is being tested?
- RF-ablation and cryo ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 10 sitesGermany
- Study dates
- Mar 2003to May 2009
- 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 old
- Clinical diagnosis of AVNRT (ECG/patients history)
- Electrophysiologically confirmed (invasively assessed) diagnosis of AVNRT
- Written informed consent
Who cannot join
- Prior ablation for AVNRT
- Congenital heart disease interfering with the ablation method
- Prior cardiac surgery
- Medical or psychiatric disorder interfering with study protocol or data acquisition
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Kerckhoffklinik GmbH EPU
Bad Nauheim, 61231
Charite Berlin Virchow - Klinikum Med. Klinik
Berlin, 13353
Universitaetsklinikum Bonn Med. Klinik II
Bonn, 53105
Evangelisches Krankenhaus Duesseldorf Kardiologie
Düsseldorf, 40217
Universitaetsklinikum Giessen EPU
Giessen, 35392
Klinikum Luedenscheid Kardiologie
Lüdenscheid, 58515
Klinikum der Stadt Mannheim Med. Klinik I
Mannheim, 68167
Deutsches Herzzentrum Muenchen
Munich, 80636
Universitaetsklinikum Tuebingen Med. Klinik/Abt.III
Tübingen, 72076
Universitaetsklinikum Ulm Innere Med. II
Ulm, 89075
About this study
Official title: European Multicenter Study RF Versus Cryo in AVNRT: A Randomized Study Comparing Cryo-Energy vs. Radiofrequency-Energy Ablation Technique for AV Nodal Reentry Tachycardia (AVNRT)
In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.
Read the detailed description
The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high.
However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach.
We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.
- Being tested
- RF-ablation, cryo ablation
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF-ablationProcedure or surgery
RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
cryo ablationProcedure or surgery
Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia Receives: Procedure: RF-ablation |
| 2 | Experimental | cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia Receives: Procedure: cryo ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data.
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 startMar 2003
- Primary completionNov 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular Nodal Reentry TachycardiaStudies 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
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- CryoCath Technologies Inc.
- Responsible party
- Sponsor
- Investigators
- Claus Schmitt, MD, Study chair, Deutsches Herzzentrum MuenchenBernhard Zrenner, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196222
- Sponsor's protocol ID
- GE IDE No. C00403
- Status last verified
- Jul 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, Hessling G. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial. Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15.
PubMed 21098435
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicenter Study RF Versus Cryo in AVNRT: A Randomized Study Comparing Cryo-Energy vs. Radiofrequency-Energy Ablation Technique for AV Nodal Reentry Tachycardia (AVNRT)
- ClinicalTrials.gov ID
- NCT00196222
- Acronym / sponsor ID
- GE IDE No. C00403
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- CryoCath Technologies Inc.
- Study start
- Mar 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- May 2009 (actual)
- 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.
In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.
Detailed description
The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high.
However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach.
We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: RF-ablationRF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
| 2 | Experimental | Procedure: cryo ablationcryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old
- Clinical diagnosis of AVNRT (ECG/patients history)
- Electrophysiologically confirmed (invasively assessed) diagnosis of AVNRT
- Written informed consent
Key exclusion criteria (4 listed)
- Prior ablation for AVNRT
- Congenital heart disease interfering with the ablation method
- Prior cardiac surgery
- Medical or psychiatric disorder interfering with study protocol or data acquisition
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-ablationRF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia | Procedure or surgery | 1 |
| cryo ablationCryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia | Procedure or surgery | 2 |
Primary outcome
Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
- Results publication: PubMed 21098435Deisenhofer I, Zrenner B, Yin YH, Pitschner HF, Kuniss M, Grossmann G, Stiller S, Luik A, Veltmann C, Frank J, Linner J, Estner HL, Pflaumer A, Wu J, von Bary C, Ucer E, Reents T, Tzeis S, Fichtner S, Kathan S, Karch MR, Jilek C, Ammar S, Kolb C, Liu ZC, Haller B, Schmitt C, Hessling G. Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial. Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15.
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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
10 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 and cryo ablation in people with Atrioventricular Nodal Reentry Tachycardia, run by Deutsches Herzzentrum Muenchen at 10 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196222, which also lists 1 linked publication.
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 4 Jul 2013.