NCT00196222

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_4

Geographic Reach
1 country

10 active sites

Status
completed

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, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 4, 2013

Status Verified

July 1, 2013

Enrollment Period

5.7 years

First QC Date

September 13, 2005

Last Update Submit

July 3, 2013

Conditions

Atrioventricular Nodal Reentry Tachycardia

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of safety and efficacy of cryo ablation compared with RF ablation for procedure and 6 months follow-up data.

    6 months

Study Arms (2)

1

EXPERIMENTAL

RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Procedure: RF-ablation

2

EXPERIMENTAL

cryo energy ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

Procedure: cryo ablation

Interventions

RF-ablationPROCEDURE

RF ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

1
cryo ablationPROCEDURE

Cryo ablation/modulation of the slow pathway in AV nodal reentrant tachycardia

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years old
  • Clinical diagnosis of AVNRT (ECG/patients history)
  • Electrophysiologically confirmed (invasively assessed) diagnosis of AVNRT
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Kerckhoffklinik GmbH EPU

Bad Nauheim, 61231, Germany

Location

Charite Berlin Virchow - Klinikum Med. Klinik

Berlin, 13353, Germany

Location

Universitaetsklinikum Bonn Med. Klinik II

Bonn, 53105, Germany

Location

Evangelisches Krankenhaus Duesseldorf Kardiologie

Düsseldorf, 40217, Germany

Location

Universitaetsklinikum Giessen EPU

Giessen, 35392, Germany

Location

Klinikum Luedenscheid Kardiologie

Lüdenscheid, 58515, Germany

Location

Klinikum der Stadt Mannheim Med. Klinik I

Mannheim, 68167, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Universitaetsklinikum Tuebingen Med. Klinik/Abt.III

Tübingen, 72076, Germany

Location

Universitaetsklinikum Ulm Innere Med. II

Ulm, 89075, Germany

Location

Related Publications (1)

  • 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.

    PMID: 21098435RESULT

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingTachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claus Schmitt, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

  • Bernhard Zrenner, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

March 1, 2003

Primary Completion

November 1, 2008

Study Completion

May 1, 2009

Last Updated

July 4, 2013

Record last verified: 2013-07

Locations

DE(10)