Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease
This study has been completed.
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01170611
First received: July 22, 2010
Last updated: July 26, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.
| Condition | Intervention | Phase |
|---|---|---|
|
Sinus Node Dysfunction Brady Tachy Syndrome |
Device: PACEMAKER SYMPHONY 2550 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease |
Resource links provided by NLM:
Further study details as provided by Sorin Group:
Primary Outcome Measures:
- Atrial arrhythmia burden [ Designated as safety issue: No ]
| Enrollment: | 400 |
| Study Start Date: | July 2004 |
| Study Completion Date: | January 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AAISAFER alone - AAISAFER+PREVENTIVE ALGORITHM - DDD | Device: PACEMAKER SYMPHONY 2550 |
Detailed Description:
In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
- A PR interval <250ms AND
- Documented atrial arrhythmia in the past year
- Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
- Patients must have less than two known cardioversions within the last year
- Patient has signed a consent form after having received the appropriate information
Exclusion Criteria:
- Need a replacement pacemaker device
- Have an unknown PR interval
- Known AV block ≥ 250 ms PR interval
- Minor and/or pregnant woman
- Patients enrolled in other clinical trials
- Patients with sustained ventricular arrhythmia
- Patients with severe coronary artery disease (at the discretion of the investigator)
- Patients with advanced cardiomyopathy (at the discretion of the investigator)
- Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
- Patients with unstable angina pectoris
- Patients whose life expectancy is less than 1 year
- Patients who are unlikely to return for required follow-up visits
- Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
- Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
- Patient unable to understand the purpose of the study or refusing to cooperate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170611
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Banner Baywood Heart Hospital | |
| Mesa, Arizona, United States, 85206 | |
| United States, California | |
| Brentwood Biomedical Research Institute | |
| Los Angeles, California, United States, 90073 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, New Jersey | |
| Passaic Beth Israel Regional Medical Center | |
| Passaic, New Jersey, United States, 07055 | |
| United States, North Carolina | |
| NorthEast Medical Center | |
| Concord, North Carolina, United States, 28025 | |
| United States, Oklahoma | |
| Hillcrest Medical Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Lancaster Regional Medical Center | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Belgium | |
| OLV Aalst | |
| Aalst, Belgium, 9300 | |
| Cliniques Sud Luxembourg | |
| Arlon, Belgium, 6700 | |
| Clinique Saint-Jean | |
| Bruxelles, Belgium, 1000 | |
| Algemeen Ziekenhuis Sint-Dimpna | |
| Geel, Belgium, 2440 | |
| Centre Hospitalier Hutois | |
| Huy, Belgium, 4500 | |
| CHU Tivoli | |
| La Louvière, Belgium, 7100 | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| UCL Mont-Godinne | |
| Yvoir, Belgium, 5530 | |
| France | |
| CHG d'Albi | |
| Albi, France, 81013 | |
| CHRU du Morvan Hôpital la Cavale Blanche | |
| Brest, France, 29069 | |
| Hospice St-Jacques-Hôpital G.Montpied | |
| Clermond-Ferrand, France, 63003 | |
| Hôpital Henri Mondor | |
| Créteil, France, 94010 | |
| C.H.I. du Val d'Ariège | |
| Foix, France, 09017 | |
| CHRU de Grenoble Hôpital Michallon | |
| Grenoble, France, 38043 | |
| Polyclinique du Bois | |
| Lille, France, 59003 | |
| CHU de Limoges Hôpital Dupuytren | |
| Limoges, France, 87042 | |
| Clinique Clairval | |
| Marseille, France, 13009 | |
| Hôpital Arnaud de Villeneuve | |
| Montpellier Cedex 5, France, 34295 | |
| Polyclinique de Gentilly | |
| Nancy, France, 54100 | |
| Nouvelles Cliniques Nantaises | |
| Nantes, France, 44277 | |
| Hôpital Pasteur | |
| Nice, France, 6000 | |
| Hôpital Pitié-Salpêtrière | |
| Paris, France, 75013 | |
| InParys CLINIQUE BIZET | |
| Paris, France, 75016 | |
| CHU Haut l'Evêque | |
| Pessac, France, 33604 | |
| CHU Pontchaillou | |
| Rennes, France, 35033 | |
| CHU - Hôpital Charles Nicolle | |
| Rouen, France, 76031 | |
| Centre Cardiologique du Nord | |
| Saint Denis, France, 93200 | |
| Centre Hospitalier Rangueil | |
| Toulouse, France, 31403 | |
| CHU Brabois | |
| Vandoeuvre Les Nancy, France, 54500 | |
| Germany | |
| Hufeland Krankenhaus GmbH | |
| Bad Langensalza, Germany, 99947 | |
| Charite Campus Virchow | |
| Berlin, Germany, 13353 | |
| Kliniken der Stadt Köln | |
| Köln, Germany, D-51067 | |
| Universitätklinikum Leipzig | |
| Leipzig, Germany, D-04103 | |
| Universitätklinik. Lübeck | |
| Lübeck, Germany, 23538 | |
| Klinikum Lüdenscheid | |
| Lüdenscheid, Germany, D-58515 | |
| Johannes Gutenberg-Universität - Mainz Klinikum | |
| Mainz, Germany, D-55101 | |
| Klinikum Memmingen | |
| Memmingen, Germany, 87700 | |
| Italy | |
| Ospedale San Tommaso dei Battuti | |
| Portogruaro, VE, Italy, 30026 | |
| Monaco | |
| CH Princesse Grace | |
| Monaco, Monaco, 98012 | |
| Spain | |
| Complejo Hospitalario Universitario de Vigo (CHUVI) | |
| Pontevedra, Spain, 36204 | |
| United Kingdom | |
| Eastbourne District General Hospital | |
| Eastbourne, East Sussex, United Kingdom, BN21 2UD | |
| St Peters Hospital | |
| Chertsey, Surrey, United Kingdom, KT16 0PZ | |
Sponsors and Collaborators
Sorin Group
More Information
No publications provided
| Responsible Party: | WIEGAND, Universitätklinik. Lübeck - Germany |
| ClinicalTrials.gov Identifier: | NCT01170611 History of Changes |
| Other Study ID Numbers: | PREFACE-IPRE03, IPRE03 |
| Study First Received: | July 22, 2010 |
| Last Updated: | July 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Atrial Premature Complexes Sick Sinus Syndrome Heart Diseases Cardiovascular Diseases |
Pathologic Processes Cardiac Complexes, Premature Arrhythmia, Sinus Heart Block |
ClinicalTrials.gov processed this record on June 17, 2013