European Carto XP Registry for Validating Specialized CFAE Software (EXPRESSO)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Biosense Webster EMEA.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Biosense Webster EMEA
Information provided by:
Biosense Webster EMEA
ClinicalTrials.gov Identifier:
NCT00812916
First received: December 19, 2008
Last updated: May 25, 2009
Last verified: May 2009
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Purpose
The purpose of this prospective observational study (registry) is to determine the acute success rate of a CFAE guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent AF in routine clinical practice.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation |
Procedure: RF ablation, using specialized CFAE software |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective Observational Multi-Centre Registry for Validating Specialized CFAE Software in Patients With Persistent or Longstanding Persistent Atrial Fibrillation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Biosense Webster EMEA:
Primary Outcome Measures:
- The primary efficacy endpoint of this registry is the acute success of the procedure. [ Time Frame: acute ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Performance of the CFAE software [ Time Frame: acute ] [ Designated as safety issue: No ]
- Procedural time point when the patient rhythm converts into Normal Sinus Rhythm [ Time Frame: acute ] [ Designated as safety issue: No ]
- Total CFAE mapping and ablation time [ Time Frame: acute ] [ Designated as safety issue: No ]
- Total RF duration [ Time Frame: acute ] [ Designated as safety issue: No ]
- Safety: frequency and type of device / procedure related adverse event [ Time Frame: acute ] [ Designated as safety issue: Yes ]
- Total fluoroscopy time [ Time Frame: acute ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 210 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
RF ablation
RF Ablation using specialized CFAE software
|
Procedure: RF ablation, using specialized CFAE software
RF ablation
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with persistent or longstanding persistent AF, needing RF ablation
Criteria
Inclusion Criteria:
- persistent or longstanding persistent AF
Exclusion Criteria:
- previously underwent RF ablation for AF and patients with paroxysmal AF
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812916
Locations
| France | |
| CHU Lille | Recruiting |
| Lille, France, 59037 | |
| Contact: Francois Brigadeau, Dr. +33 3 20 44 59 62 | |
| Hopital Saint Joseph | Recruiting |
| Marseille, France, 13001 | |
| Contact: André Pisapia, Dr. +33 4 91 74 20 11 | |
| Contact: Michel Bremondy, Dr. +33 4 91 74 20 11 | |
| CHU Arnaud de Villeneuve | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Jean-Luc Pasquie, Dr. +33 4 67 33 67 33 | |
| Contact: Franck Raczka, Dr. +33 4 67 33 67 33 | |
| CHU Hôpital de Brabois | Recruiting |
| Nancy, France, 54500 | |
| Contact: Ahmed Abdelaal, Dr. +33 3 83 85 85 85 | |
| CHU Nantes | Recruiting |
| Nantes, France, 44000 | |
| Contact: Gilles Lande, Dr. +33 2 40 08 33 33 | |
| Contact: Selim Abbey, Dr. +33 2 40 08 33 33 | |
| Ambroise Paré | Recruiting |
| Neuilly, France, 92200 | |
| Contact: Bruno Cauchemez, Dr. +33 1 46 41 88 88 | |
| Hopital Les Franciscaines | Recruiting |
| Nimes, France | |
| Contact: Augustine Bortone, Dr. +33 8 26 30 50 00 | |
| Hôpital Lariboisière | Not yet recruiting |
| Paris, France, 75010 | |
| Contact: Fabrice Extramiana, Dr. +33 1 42 17 76 60 | |
| Clinique Pasteur | Not yet recruiting |
| Toulouse, France, 31076 | |
| Contact: Jean-Paul Albenque, Dr. +33 5 62 21 31 31 | |
| Germany | |
| Klinik St. Georg | Recruiting |
| Hamburg, Germany | |
| Contact: Boris Schmidt, Dr. +49 40 18 18 85 2305 | |
| Stadtisches Klinikum Karlsruhe | Recruiting |
| Karlsruhe, Germany | |
| Contact: Armin Luik, Dr. +49 7 219 74 2901 | |
| Universität Rostock | Not yet recruiting |
| Rostock, Germany | |
| Contact: Dietmar Bansch, Prof. +49 38 14 94 77 06 | |
| Hungary | |
| GOKI | Terminated |
| Budapest, Hungary | |
Sponsors and Collaborators
Biosense Webster EMEA
More Information
No publications provided
| Responsible Party: | Ilse Van Keer, Biosense Webster EMEA |
| ClinicalTrials.gov Identifier: | NCT00812916 History of Changes |
| Other Study ID Numbers: | EXPRESSO |
| Study First Received: | December 19, 2008 |
| Last Updated: | May 25, 2009 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Biosense Webster EMEA:
|
persistent or longstanding persistent atrial fibrillation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013