Atrioventricular Block Clinical Trial
— PRECISEOfficial title:
Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation
Verified date | October 2017 |
Source | LivaNova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Observational study on long PR interval using the SafeR mode in bradycardia patients.
Status | Completed |
Enrollment | 848 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient implanted (primo-implant, replacement, upgrade) with a Sorin Group™ dual chamber pacemaker according to current available guidelines and IFU from less than three months. - Since implantation, the device is programmed in SafeR mode - Patient agreed to participate, after having received the appropriate and mandatory information Exclusion Criteria: - Patient contraindicated for cardiac pacing, according to current available guidelines - Permanent atrial fibrillation - Permanent high-degree AV block - Patient not available for routine follow-up visits - Patient already included in another clinical study - Inability to understand the purpose of the study / refusal to cooperate - minor age - Pregnancy - Life expectancy less than 12 months - Under guardianship |
Country | Name | City | State |
---|---|---|---|
France | CH du Pays d'Aix | Aix-en-Provence | |
France | CH Alençon | Alençon | |
France | Cabinet Alès | Alès | |
France | hôpital Sud | Amiens | |
France | CH Annecy | Annecy | |
France | hôpital privé Antony | Antony | |
France | hôpital d'Argenteuil | Argenteuil | |
France | hôpital St André | Bordeaux | |
France | CH Bourges | Bourges | |
France | CHU Brest | Brest | |
France | Clinique Keraudren | Brest | |
France | CHU Caen | Caen | |
France | Clinique des 2 Caps | Calais | |
France | CH Chartres | Chartres | |
France | Ch Chaumont | Chaumont | |
France | Cabinet Cherbourg | Cherbourg | |
France | HIA Percy | Clamart | |
France | Hôpital L. Pasteur | Colmar | |
France | CH Corbeil Essonnes | Corbeil Essonnes | |
France | Hopital Henri Mondor | Créteil | |
France | Cabinet Creutzwald | Creutzwald | |
France | CH Dinan | Dinan | |
France | CH Douarnenez | Douarnenez | |
France | CH Evreux | Evreux | |
France | CMCO Evry | Evry | |
France | Cabinet Forbach | Forbach | |
France | CH Forbach | Forbach | |
France | CH Haguenau | Haguenau | |
France | CH Helfaut | Helfaut | |
France | CH Lannion | Lannion | |
France | CH Le Havre | Le Havre | |
France | CMCM Le Mans | Le Mans | |
France | CMC Port Marly | Le Port-Marly | |
France | CH Lomme | Lomme | |
France | CH Lorient | Lorient | |
France | CHU La Timone | Marseille | |
France | Hôpital Nord | Marseille | |
France | Clinique Melun | Melun | |
France | CH Privé Metz | Metz | |
France | CH Montfermeil | Montfermeil | |
France | Clinique Montpellier | Montpellier | |
France | Clinique A. Paré | Nancy | |
France | NCN Nantes | Nantes | |
France | CH Orléans | Orléans | |
France | Cabinet Paris | Paris | |
France | CH St Joseph | Paris | |
France | CH Poissy St Germain | Poissy | |
France | CHU Poitiers | Poitiers | |
France | Clinique St Hilaire | Rouen | |
France | CCN St Denis | Saint Denis | |
France | CH St Nazaire | Saint Nazaire | |
France | CH Sens | Sens | |
France | CH St Malo | St Malo | |
France | CH Basse Terre | Terre Basse | Guadeloupe |
France | CH Thionville | Thionville | |
France | CH Valenciennes | Valenciennes | |
France | Cabinet Valognes | Valognes | |
France | CH Villefrance | Villefranche Sur Saone |
Lead Sponsor | Collaborator |
---|---|
LivaNova |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prolonged PR interval (> 200ms) in patients without AVB I at baseline (Incidence of "clinical" AVB1) | This incidence will be measured using PR/AR histograms stored in the device memory | at 12 months |
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