Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2

Completed

• Conditions: Bradyarrhythmia

• Registration Number: NCT01715558
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-29
• Study Start: 2013-02
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Combined event rate of all-cause mortality, cardiovascular hospitalizations and atrial fibrillation at 2 years stratified per patient characteristics.	2 years	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.

Trial Locations

Locations (39)

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Belgium

Vejle Sygehus; 🇩🇰 Vejle, Denmark

Regionshospitalet Herning; 🇩🇰 Herning, Denmark

CHRU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHRU Angers; 🇫🇷 Angers, France

CHU Grenoble - Hopital Michallon; 🇫🇷 Grenoble, France

Universitätsklinikum; 🇩🇪 Leipzig, Germany

Ospedale Cardinal Massaia; 🇮🇹 Asti, Italy

Ospedale Santa Maria degli Angeli; 🇮🇹 Pordenone, Italy

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

St. Elisabeth Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Hospital San Pedro; 🇪🇸 Logroño, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Blackpool Victoria; 🇬🇧 Blackpool, United Kingdom

Hospital de Torrejón; 🇪🇸 Torrejón, Spain

Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse; 🇧🇪 Hasselt, Belgium

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

St.-Marien-Hospital GmbH; 🇩🇪 Lünen, Germany

Deutsches Herzzentrum München; 🇩🇪 München, Germany

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

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

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Gelre Ziekenhuis Zutphen; 🇳🇱 Zutphen, Netherlands

SUSCCH a.s.; 🇸🇰 Banska Bystrica, Slovakia

The National Institute of Cardiovascular Diseases; 🇸🇰 Bratislava, Slovakia

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Viborg Sygehus; 🇩🇰 Viborg, Denmark