Evia/Entovis HF-T Master Study
This study is currently recruiting participants.
Verified April 2012 by Biotronik SE & Co. KG
Sponsor:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01545739
First received: March 1, 2012
Last updated: April 19, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Indication for Cardiac Resynchronization Therapy (CRT) |
Device: Evia/Entovis HF-T pacemaker for CRT therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Master Study of the Evia/Entovis HF-T Pacemaker |
Further study details as provided by Biotronik SE & Co. KG:
Primary Outcome Measures:
- Safety: Serious Adverse Device Effect (SADE) free rate [ Time Frame: Until 3 month follow-up ] [ Designated as safety issue: Yes ]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)%.
- Efficacy of the left ventricular capture control feature (focus on threshold measurements) [ Time Frame: At pre-hospital discharge, 1 and 3 month follow-up ] [ Designated as safety issue: No ]Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.
Secondary Outcome Measures:
- Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment) [ Time Frame: 1 and 3 month follow-up ] [ Designated as safety issue: No ]Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%.
| Estimated Enrollment: | 115 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| CRT pacemaker implantation |
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545739
Contacts
| Contact: Evelyn Ina Diessel, Dr. | +49 30 68905 ext 1231 | evelyn.diessel@biotronik.com |
Locations
| Hungary | |
| Semmelweis University | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Béla Merkely, Prof., MD, PhD merkely.bela@kardio.sote.hu | |
Sponsors and Collaborators
Biotronik SE & Co. KG
More Information
No publications provided
| Responsible Party: | Biotronik SE & Co. KG |
| ClinicalTrials.gov Identifier: | NCT01545739 History of Changes |
| Other Study ID Numbers: | 57 |
| Study First Received: | March 1, 2012 |
| Last Updated: | April 19, 2012 |
| Health Authority: | Austria: AGES, Bundesamt für Sicherheit im Gesundheitswesen |
Keywords provided by Biotronik SE & Co. KG:
|
Pacemaker therapy Cardiac resynchronisation therapy (CRT) |
ClinicalTrials.gov processed this record on May 19, 2013