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

Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

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.

Study Overview

• Status: Completed
• Conditions: Bradyarrhythmia

• Study Type: Observational
• Enrollment (Actual): 514

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Hasselt, Belgium
    • Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
• Denmark
  • Herning, Denmark
    • Regionshospitalet Herning
  • Vejle, Denmark
    • Vejle Sygehus
  • Viborg, Denmark
    • Viborg Sygehus
• France
  • Angers, France
    • CHRU Angers
  • Clermont-Ferrand, France
    • CHRU de Clermont-Ferrand
  • Grenoble, France
    • CHU Grenoble - Hôpital MICHALLON
  • Nancy, France
    • Service de cardiologie, CHU Nancy-Brabois
  • Nantes, France
    • CHU de Nantes-Hopital Laennec
  • Pau, France
    • Centre Hospitalier Général de Pau
  • Poitiers, France
    • CHU Poitiers - Hôpital la Milétrie
  • la Roche sur Yon, France
    • Hôpital la Roche sur Yon
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Leipzig, Germany
    • Universitätsklinikum
  • Lünen, Germany
    • St.-Marien-Hospital GmbH
  • München, Germany
    • Deutsches Herzzentrum Munchen
• Italy
  • Asti, Italy
    • Ospedale Cardinal Massaia
  • Bari, Italy
    • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  • Bologna, Italy
    • Policlinico S. Orsola - Malpighi
  • Casarano (LE), Italy
    • Pres. Osp. F. Ferrari
  • Castellammare di Stabia, Italy
    • Ospedale Civile San Leonardo
  • Pisa, Italy
    • Fondazione Toscana Gabriele Monasterio
  • Pordenone, Italy
    • Ospedale Santa Maria degli Angeli
  • Pozzuoli, Italy
    • P.O. Santa Maria Delle Grazie
  • Prato, Italy
    • Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO
  • Rome, Italy
    • Policlinico Tor Vergata
  • Rome, Italy
    • Azienda Ospedaliera Sant'Andrea
• Netherlands
  • Ede, Netherlands
    • Ziekenhuis Gelderse Vallei
  • Leeuwarden, Netherlands
    • Medisch Centrum Leeuwarden
  • Tilburg, Netherlands
    • St. Elisabeth Ziekenhuis
  • Zutphen, Netherlands
    • Gelre Ziekenhuis Zutphen
• Slovakia
  • Banska Bystrica, Slovakia
    • SUSCCH a.s.
  • Bratislava, Slovakia
    • The National Institute of Cardiovascular Diseases
• Spain
  • Badajoz, Spain
    • Hospital Universitario Infanta Cristina
  • Logroño, Spain
    • Hospital San Pedro
  • Torrejón, Spain
    • Hospital de Torrejón
• United Kingdom
  • Blackpool, United Kingdom
    • Blackpool Victoria
  • London, United Kingdom
    • Barts Health NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with permanent pacemaker with RYTHMIQ programed to ON

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RYTHMIQ study group
Historical control from OPTI-MIND

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	2 years

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 24, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: CDM00053871 / 90942887