BIO|MASTER.Edora Family Study

Cardiac Resynchronization Therapy Clinical Trial

Official title:

BIO|MASTER.Edora Family Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03091322
• Other study ID #: BA106
• Status: Completed
• Start date: February 12, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: January 2020
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.

Description:

Study Design

• Open-label, prospective, non-randomized, multicenter, international

• about 13 study sites

Study Endpoints

The following endpoints are defined and will be assessed with descriptive analysis:

1. AV Opt feature:

The feature's AV delay recommendation was

1. used as basis for the device programming or is at least considered to be clinically acceptable or

2. other AV delay values were chosen by the investigator and the recommendation was rated as not clinically acceptable.

2. LV VectorOpt usability using an overall score (categories: excellent, good, average, fair, poor).

3. (S)ADEs and calculation of the SADE free rate until the 6-month follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Standard indication for pacemaker therapy or cardiac resynchronization therapy

• Patient is able to understand the nature of the study;

• Patient provides written informed consent;

• Patient is able and willing to complete the planned follow-up visits at the investigational site;

• Patient accepts Home Monitoring® concept;

• Age = 18 years.

Exclusion Criteria:

• Any contraindication for pacemaker or cardiac resynchronization therapy (whichever applies);

• Patient has received or is planned to receive an epicardial LV lead implant;

• Pregnant or breast-feeding;

• Life expectancy of less than 6 months;

• Participation in an interventional clinical investigation

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Pacemaker Therapy

Intervention

Device:
• Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8
Assessment of the AV Opt and LV VectorOpt features

Locations

Country	Name	City	State
Austria	Kepler Universitätsklinikum	Linz
Germany	Maria Heimsuchung - Caritas-Klinik Pankow	Berlin
Germany	Herzzentrum Bernau	Bernau
Germany	Städtisches Klinikum Brandenburg GmbH	Brandenburg
Germany	Klinikum St. Georg gGmbH	Leipzig
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg
Germany	Niels-Stensen-Kliniken, Marienhospital Osnabrück	Osnabrück
Germany	Universitätsklinikum Würzburg	Würzburg
Germany	Heinrich-Braun-Klinikum gemeinnützige GmbH	Zwickau
Spain	Clínica Universitaria de Navarra (CUN)	Pamplona
Switzerland	Luzerner Kantonsspital (LUKS)	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Germany,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AV delay recommendation by the AV Opt Feature was either used for the device programming or was rated as clinically acceptable.	The AV Opt Feature will be assessed only for patients with triple-chamber devices and patients with dual-chamber devices (if clinically indicated) with sinus rhythm of sufficient intrinsic rate. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.	until the 1-month follow-up
Primary	Overall score for the usability of the LV VectorOpt feature	The LV VectorOpt feature has to be assessed for patients with an HF-T device (triple-chamber) and a QP lead (quadripolar, HF-T QP group) only. According to the clinical investigation plan this endpoint will be assessed with descriptive analysis methods.	until the 1-month follow-up
Primary	(S)ADEs and calculation of the SADE free rate	Descriptive analysis of all (S)ADEs and calculation of the SADE free rate	until the 6-month follow-up