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

Bradyarrhythmia Clinical Trial

— OPTI-MIND 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715558
• Other study ID #: CDM00053871 / 90942887
• Status: Completed
• Phase: N/A
• First received: October 15, 2012
• Last updated: May 8, 2017
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bradyarrhythmia
• Bradycardia

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse	Hasselt
Denmark	Regionshospitalet Herning	Herning
Denmark	Vejle Sygehus	Vejle
Denmark	Viborg Sygehus	Viborg
France	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
Germany	Herz- und Diabeteszentrum Nordrhein-Westfalen	Bad Oeynhausen
Germany	Universitätsklinikum	Leipzig
Germany	St.-Marien-Hospital GmbH	Lünen
Germany	Deutsches Herzzentrum München	München
Italy	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
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Netherlands	Gelre Ziekenhuis Zutphen	Zutphen
Slovakia	SUSCCH a.s.	Banska Bystrica
Slovakia	The National Institute of Cardiovascular Diseases	Bratislava
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital San Pedro	Logroño
Spain	Hospital de Torrejón	Torrejón
United Kingdom	Blackpool Victoria	Blackpool
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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