Evia/Entovis HF-T Master Study

Indication for Cardiac Resynchronization Therapy (CRT) Clinical Trial

Official title:

Master Study of the Evia/Entovis HF-T Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545739
• Other study ID #: 57
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: October 15, 2014
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: AGES, Bundesamt für Sicherheit im Gesundheitswesen
• Study type: Observational

Clinical Trial Summary

The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Standard indication for CRT therapy

• Legal capacity and ability to consent

• Signed patient informed consent

Exclusion Criteria:

• Contraindication for CRT therapy

• ICD indication

• Age < 18 years

• Pregnant or breast-feeding woman

• Cardiac surgery planned within the next 6 months

• Life expectancy of less than 6 months

• Participating in another clinical study of an investigational cardiac drug or device

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Indication for Cardiac Resynchronization Therapy (CRT)

Intervention

Device:
• Evia/Entovis HF-T pacemaker for CRT therapy
Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Serious Adverse Device Effect (SADE) free rate	While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%.	Until 3 month follow-up	Yes
Primary	Efficacy of the left ventricular capture control feature (focus on threshold measurements)	Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.	At pre-hospital discharge, 1 and 3 month follow-up	No
Secondary	Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)	Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%.	1 and 3 month follow-up	No