Clinical trial NCT01715558: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2
Official title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradyarrhythmia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with permanent pacemaker with RYTHMIQ programed to ON

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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
3. Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

1. Patients with 3rd degree AV block
2. Patients with permanent AF
3. Patients followed up remotely with remote patient management system.
4. Patients who are unable to be followed up by the participating centers for a period of two years
5. Patients who have a current device implanted for more than 15 days
6. 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)
7. 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.
timeFrame: 2 years
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Hasselt
country: Belgium
facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
city: Herning
country: Denmark
facility: Regionshospitalet Herning
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Angers
country: France
facility: CHRU Angers
city: Clermont-Ferrand
country: France
facility: CHRU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble - Hopital Michallon
city: la Roche sur Yon
country: France
facility: Hôpital la Roche sur Yon
city: Nancy
country: France
facility: Service de cardiologie, CHU Nancy-Brabois
city: Nantes
country: France
facility: CHU de Nantes-Hopital Laennec
city: Pau
country: France
facility: Centre Hospitalier Général de Pau
city: Poitiers
country: France
facility: CHU Poitiers - Hôpital La Miletrie
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Asti
country: Italy
facility: Ospedale Cardinal Massaia
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi
city: Casarano (LE)
country: Italy
facility: Pres. Osp. F. Ferrari
city: Castellammare di Stabia
country: Italy
facility: Ospedale Civile San Leonardo
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
city: Pordenone
country: Italy
facility: Ospedale Santa Maria degli Angeli
city: Pozzuoli
country: Italy
facility: P.O. Santa Maria Delle Grazie
city: Prato
country: Italy
facility: Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO
city: Rome
country: Italy
facility: Azienda ospedaliera Sant'Andrea
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuis Zutphen
city: Banska Bystrica
country: Slovakia
facility: SUSCCH a.s.
city: Bratislava
country: Slovakia
facility: The National Institute of Cardiovascular Diseases
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Torrejón
country: Spain
facility: Hospital de Torrejón
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
References: