Patients Implanted With a Pacemaker Clinical Trial
— NATUREOfficial title:
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers
| Verified date | November 2017 |
| Source | LivaNova |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.
| Status | Completed |
| Enrollment | 1440 |
| Est. completion date | December 2011 |
| Est. primary completion date | December 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Sinus Node Disease - Brady-Tachy Syndrome - Suspected or documented paroxysmal AVB Exclusion Criteria: - Permanent high degree AVB - Contra indication to the SafeR pacing mode - PR higher than 350 ms |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Az St- Blasius | Dendermonde | |
| Belgium | Ch de Huy | HUY | |
| Belgium | Heilig Hart Ziekenhuis MOL | MOL | |
| Canada | Hospital Hamilton | Hamilton | |
| Canada | Niagara Health System | Niagara | |
| Denmark | Bispebjerg Hospital | Bispebjerg | |
| Denmark | HELLERUP | Gentofte Hospital | |
| 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 | Chu Pessac | Bordeaux | |
| France | Clinique Des Pins Francs | 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 | Ch Le Havre | Le Havre | |
| France | Chu Le Havre | Le Havre | |
| France | Hôpital Cardiologique | Lyon | |
| France | Chu La Timone | Marseille | |
| France | Hôpital Nord | 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 | Clinique Parc Monceau | Paris | |
| France | Hôpital Val de Grâce | 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 | |
| Germany | Erzgebirgsklinikum ANNABERG | Annaberg | |
| Germany | Schade Stolz Rötech | Berlin | |
| Germany | Klinikum Bogenhausen | Bogenhausen | |
| Germany | Klinikum Dresden | Dresden | |
| Germany | PRAXIS Dr Subin und Lutter | Hamburg | |
| Italy | Hospital Montebelluna | Montebelluna | |
| Italy | Hospital Negrar | Negrar | |
| Italy | Casa di Cura Pederzoli | Peschiera del Garda | |
| 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 | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Portugal | Hospital Garcia Orta | Almada | |
| Portugal | Hospital de Santa Cruz | Carnaxide | Lisboa |
| 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 | |
| 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 | |
| United States | Baptist Princeton Birmingham | Birmingham | Alabama |
| United States | Cardiovascular Assoc. Of Mesa | Mesa | Arizona |
| United States | University of Mississippi Medical Center | Mississippi | Mississippi |
| United States | Piedmont hospital | Piedmont | Georgia |
| United States | O'Connor Hospital San Jose | San Jose | California |
| United States | Tennessee Valley Sheffield | Sheffield | Alabama |
| United States | St. Francis Hospital Tulsa | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| LivaNova |
United States, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Portugal, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | High degree AV blocks | 2 years |