Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
OPTI-MIND 2
1 other identifier
observational
514
9 countries
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMay 9, 2017
February 1, 2017
3.8 years
October 15, 2012
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.
2 years
Study Arms (2)
RYTHMIQ study group
Historical control from OPTI-MIND
Eligibility Criteria
Patients implanted with permanent pacemaker with RYTHMIQ programed to ON
You may qualify if:
- Patients implanted with any of BSC dual chamber PM devices equipped with RHYTMIQ with the algorithm programed to ON based on clinical indication at the time of discharge from the hospital
- Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center
- Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
You may not qualify if:
- Patients with 3rd degree AV block
- Patients with permanent AF
- Patients followed up remotely with remote patient management system.
- Patients who are unable to be followed up by the participating centers for a period of two years
- Patients who have a current device implanted for more than 15 days
- Women of childbearing potential who are pregnant, or plan to become pregnant during the time of the study (method of assessment upon physician's discretion)
- Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Ziekenhuis Oost Limburg
Genk, 3600, Belgium
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 29, 2012
Study Start
February 1, 2013
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
May 9, 2017
Record last verified: 2017-02