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Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers (NATURE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Sorin Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT00531037
First received: September 17, 2007
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

Recent studies have shown the importance of preserving spontaneous atrio-ventricular conduction in patients implanted with an implantable cardiac pacemaker.

The SafeR/AAISafeR pacing mode, developed by Sorin Group/ELA Medical and available on Reply and SymphonyTM dual-chamber pacemakers, provides physiological atrial pacing while ensuring ventricular backup pacing in case of AV block in patients implanted for Sinus Dysfunction, Brady Tachy Syndrome or paroxysmal Atrio Ventricular block3 (AV block).

Memory functions (EGM episodes and Marker chains) available with the SafeR/AAISafeR pacing mode have been used until now to verify the safety of the algorithm. However, these stored EGM episodes and Marker chains may also provide precious information related to the nature of the AV block and the evolution of conduction disorders through time.

So far no studies have been carried out on this subject using the latest generation of pacemakers. This results from the unavailability of any diagnostic tool in currently marketed devices. Studies reporting the incidence of AV block in patients implanted for Sinus Dysfunction are based only on the occurrence of symptomatic AV block and/or the observation of conduction disorders on surface ECG during follow-up4,5.

The diagnostic functions available with the SafeR/AAISafeR mode enable to diagnose and record in device memory all AV blocks, regardless of the degree of the AV block and the symptom(s) of the patient. Therefore, this unique diagnostic tool could enable to determine the nature and to analyze through time the evolution of conduction disorders in patients implanted for Sinus Dysfunction, Brady Tachy Syndrome or paroxysmal Atrio Ventricular block, in order to better identify the indications for implant and to provide further appropriate pacing mode.

The observational study will enable to compile all these device memory data in order to directly assess statistical analysis of AV block incidence and evolution according to the nature of the AV block, the incidence of paroxysmal atrial arrhythmias, the anti arrhythmic drugs medication and other.


Condition
Sinus Node Dysfunction
Brady Tachy Syndroma Population

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • High degree AV blocks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 1440
Study Start Date: June 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient primo-implanted with a Symphony ™ DR2550, Symphony ™ D 2450, Reply DR, Reply D pacemaker or any similar or higher range device less than three months ago, programmed in SafeR/AAISafeR mode.

Criteria

Inclusion Criteria:

  • SND
  • BTS
  • Suspected paroxysmal AVB
  • Documented paroxysmal AVB

Exclusion Criteria:

  • Permanent high degree AVB
  • Contra indication to the SafeR pacing mode
  • PR higher than 350 ms
  • Life expectancy lower than 12 months
  • Inability or refusal to participate to the study
  • Not available for follow ups
  • Minors or pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531037

  Hide Study Locations
Locations
United States, Alabama
Baptist Princeton Birmingham
Birmingham, Alabama, United States
Tennessee Valley Sheffield
Sheffield, Alabama, United States
United States, Arizona
Cardiovascular Assoc. Of Mesa
Mesa, Arizona, United States
United States, California
O'Connor Hospital San Jose
San Jose, California, United States
United States, Georgia
Piedmont hospital
Piedmont, Georgia, United States
United States, Mississippi
University of Mississippi Medical Center
Mississippi, Mississippi, United States
United States, Oklahoma
St. Francis Hospital Tulsa
Tulsa, Oklahoma, United States
Belgium
Az St- Blasius
Dendermonde, Belgium
Ch de Huy
HUY, Belgium
Heilig Hart Ziekenhuis MOL
MOL, Belgium
Canada
Hospital Hamilton
Hamilton, Canada
Niagara Health System
Niagara, Canada
Denmark
Bispebjerg Hospital
Bispebjerg, Denmark
HELLERUP
Gentofte Hospital, Denmark
France
Clinique Esquirol
Agen, France
CH Albi
Albi, France
Clinique Claude Bernard
Albi, France
CH ALES
Ales, France
Clinique Bonnefond
Ales, France
Cabinet Prive
Annecy, France
Clinique Aressy
Aressy, France
CH AUCH
Auch, France
Clinique Paulmy
Bayonne, France
Ch Beauvais
Beauvais, France
Clinique St Vincent
Besancon, France
Ch Beziers
Beziers, France
Clinique Aguilera
Biarritz, France
Clinique Des Pins Francs
Bordeaux, France
Chu Pessac
Bordeaux, France
Ch Boulogne
Boulogne Sur Mer, France
Chu Brest
Brest, France
CH BRIVE
Brive, France
Ch Calais
Calais, France
Clinique Des 2 Caps
Calais, France
Ch Carcassonne
Carcassonne, France
Chu Ceret
Ceret, France
Ch Chalons
Chalons En Champagne, France
Clinique Bon Secours
Chatellerault, France
Ch Chaumont
Chaumont, France
Ch Cherbourg
Cherbourg, France
Ch Colmar
Colmar, France
Cabinet Cardiologie Creutzwald
Creutzwald, France
Polyclinique Du Parc
Croix, France
CH DINAN
Dinan, France
CH DOLE
Dole, France
CH DOUAI
Douai, France
Ch Douarnenez
Douarnenez, France
Polyclinique Notre Dame
Draguignan, France
Hôpital Emile Roux
Eaubonne, France
Centre Cardiologique D'Evecquemont
Evecquemont, France
Hôpital D'Evreux
Evreux, France
Ch Firminy
Firminy, France
Ch Forbach
Forbach, France
Ch Freyming
Freyming Merlebach, France
CH GAP
GAP, France
Ch Lannion
Lannion, France
Cmc Parly Ii
Le Chesnay, France
Chu Le Havre
Le Havre, France
Ch Le Havre
Le Havre, France
Hôpital Cardiologique
Lyon, France
Hôpital Nord
Marseille, France
Chu La Timone
Marseille, France
Chg Martigues
Martigues, France
Institut Hospitalier Jacques Cartier
Massy, France
Hôpital Ste Blandine
Metz, France
Clinique Pont Chaume
Montauban, France
Hôpital Le Raincy Monfermeil
Montfermeil, France
Chu Montpellier
Montpellier, France
Clinique Plein Ciel
Mougins, France
Ch Moulins
Moulins, France
Clinique Du Diaconnat
Mulhouse, France
Centre Chirurgical Ambroise Pare
Neuilly Sur Seine, France
Ch Nevers
Nevers, France
Clinique Des Fleurs
Ollioules, France
Ch Orange
Orange, France
Clinique Bizet
Paris, France
Hôpital Val de Grâce
Paris, France
Clinique Parc Monceau
Paris, France
CHU PAU
PAU, France
Ch Perpignan
Perpignan, France
Chu Poitiers
Poitiers, France
Centre Medico Chirurgical de L'Europe
Port Marly, France
Hôpital Prive Claude Galien
Quincy Sous Senart, France
Clinique Pasteur
Ris Orangis, France
CH RODEZ
Rodez, France
Clinique St Hilaire Rouen
Rouen, France
Polyclinique de Montier La Celle
Saint André Les Vergers, France
Clinique Notre Dame
Saint Die Des Vosges, France
Hôpital Prive Nord Parisien
Sarcelles, France
Centre Cardiologique Du Nord
St Denis, France
Ch St Malo
St Malo, France
Cmc Ste Feyre
Ste Feyre, France
Clinique St Gatien
Tours, France
Clinique Vauban
Valenciennes, France
Germany
Erzgebirgsklinikum ANNABERG
Annaberg, Germany
Schade Stolz Rötech
Berlin, Germany
Klinikum Bogenhausen
Bogenhausen, Germany
Klinikum Dresden
Dresden, Germany
PRAXIS Dr Subin und Lutter
Hamburg, Germany
Italy
Hospital Montebelluna
Montebelluna, Italy
Hospital Negrar
Negrar, Italy
Casa di Cura Pederzoli
Peschiera del Garda, Italy
Japan
Kanagawa Cardiov. and Respiratory Center
Kanagawa, Japan
Kokura Memorial Hospital
Kokura, Japan
Konan St Hill Hospital
Konan, Japan
Yokosuka Kyosai General Hospital
Kyosai, Japan
Mie University Hospital
MIE, Japan
Nara Hospital, Kinki University School of Medicine
Nara, Japan
Ogikubo Hospital
Ogikubo, Japan
Saiseikai Noe Hospital
Saiseikai Noe, Japan
Tokai University School of Medicine
Tokai, Japan
Tokio Metropolitan Geriatric Hospital
Tokio, Japan
Yokohama City University Hospital
Yokohama, Japan
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Portugal
Hospital de Santa Cruz
Carnaxide, Lisboa, Portugal
Hospital Garcia Orta
Almada, Portugal
Hospital Central Faro
Faro, Portugal
Hospital Egas Moniz
Lisboa, Portugal
Hospital Santa Maria
Lisboa, Portugal
Hospital Santa Marta
Lisboa, Portugal
Hospital São Francisco Xavier
Lisboa, Portugal
Hospital Distrital de Santarém
Santarem, Portugal
Spain
Hospital Marina Alta
Denia, Spain
Hospital General de Elda
Elda, Spain
Hospital de Cabuenes
Gijon, Spain
Hospital Vega Baja
Orihuela, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital La Fe
Valencia, Spain
Meixoeiro
Vigo, Spain
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: DEHARO Jean Claude, MD CHU la Timone - Marseille
  More Information

No publications provided

Responsible Party: Borri-Brunetto, Sorin group
ClinicalTrials.gov Identifier: NCT00531037     History of Changes
Other Study ID Numbers: Nature - RGST01, RGST01
Study First Received: September 17, 2007
Last Updated: June 15, 2010
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Germany: Ethics Commission
Italy: Ethics Committee
Spain: Ethics Committee

Keywords provided by Sorin Group:
AV block, SND, BTS, AAIsafeR, SafeR, PM implanted

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Block
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014