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The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYTHMIQ study group | |||
| Historical control from OPTI-MIND |
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| Measure | Description | Time Frame |
|---|---|---|
| Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature | Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years in a specific Brady population implanted with BSC PM devices equipped with RYHTMIQ feature compared to data from a cohort of subjects implanted with BSC PM without RYTHMIQ pooled from OPTI-MIND study. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics. | A multivariate model will be used to find the independent association with the combined primary endpoint, RYTHMIQ algorithm and other patient characteristics. Variables of interests include (but are not limited to): primary pacing indication (SND vs AVB), degree of AVB, age, gender, underlying disease, use of Betablockers, history of atrial fibrillation, LVEF, NYHA class, RV lead position, type of sensors used. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium | |||
| Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse |
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| 2 years |
| Hasselt |
| Belgium |
| Regionshospitalet Herning | Herning | Denmark |
| Vejle Sygehus | Vejle | Denmark |
| Viborg Sygehus | Viborg | Denmark |
| CHRU Angers | Angers | France |
| CHRU de Clermont-Ferrand | Clermont-Ferrand | France |
| CHU Grenoble - Hopital Michallon | Grenoble | France |
| Hôpital la Roche sur Yon | La Roche-sur-Yon | France |
| Service de cardiologie, CHU Nancy-Brabois | Nancy | France |
| CHU de Nantes-Hopital Laennec | Nantes | France |
| Centre Hospitalier Général de Pau | Pau | France |
| CHU Poitiers - Hôpital La Miletrie | Poitiers | France |
| Herz- und Diabeteszentrum Nordrhein-Westfalen | Bad Oeynhausen | Germany |
| Universitätsklinikum | Leipzig | Germany |
| St.-Marien-Hospital GmbH | Lünen | Germany |
| Deutsches Herzzentrum München | München | Germany |
| Ospedale Cardinal Massaia | Asti | Italy |
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | Italy |
| Policlinico S. Orsola - Malpighi | Bologna | Italy |
| Pres. Osp. F. Ferrari | Casarano (LE) | Italy |
| Ospedale Civile San Leonardo | Castellammare di Stabia | Italy |
| Fondazione Toscana Gabriele Monasterio | Pisa | Italy |
| Ospedale Santa Maria degli Angeli | Pordenone | Italy |
| P.O. Santa Maria Delle Grazie | Pozzuoli | Italy |
| Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO | Prato | Italy |
| Azienda ospedaliera Sant'Andrea | Rome | Italy |
| Policlinico Tor Vergata | Rome | Italy |
| Ziekenhuis Gelderse Vallei | Ede | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | Netherlands |
| Gelre Ziekenhuis Zutphen | Zutphen | Netherlands |
| SUSCCH a.s. | Banská Bystrica | Slovakia |
| The National Institute of Cardiovascular Diseases | Bratislava | Slovakia |
| Hospital Universitario Infanta Cristina | Badajoz | Spain |
| Hospital San Pedro | Logroño | Spain |
| Hospital de Torrejón | Torrejón | Spain |
| Blackpool Victoria | Blackpool | United Kingdom |
| Barts Health NHS Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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