BIO|MASTER.Edora Family Study

Biotronik

Status: Completed

Conditions: Pacemaker Therapy; Cardiac Resynchronization Therapy

Treatments: Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

Study type: Observational

Funder types: Industry

Identifiers

NCT03091322

BA106

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 4 patient groups

SR-T group

Description:

single chamber pacemaker

Treatment:

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

DR-T group

Description:

dual chamber pacemaker

Treatment:

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

HF-T group

Description:

triple chamber pacemaker (IS-1 connector)

Treatment:

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

HF-T QP group

Description:

triple chamber pacemaker (with IS4 connector) and a lead of the Sentus QP lead family

Treatment:

Device: Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8