Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker

Not Applicable

Completed

• Conditions: Pacemaker Indication
• Interventions: Device: EVIA Pacemaker

• Registration Number: NCT00916344
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Primary Completion: 2010-02
• Study Completion: 2010-03
• Results First Submitted: 2011-07-27
• Results First Submitted QC: 2011-08-24
• Results First Posted: 2011-09-30
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Meet the indications for pacemaker therapy
• Understand the nature of the procedure
• Give informed consent
• Able to complete all testing required by the clinical protocol
• Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria

• Meet none of the pacemaker indications
• Meet one or more of the contraindications
• Patients with chronic atrial fibrillation (dual chamber pacemaker only)
• Have a life expectancy of less than six months
• Cardiac surgery in the next six months
• Enrolled in another cardiac clinical investigation
• Have other medical devices that may interact with the implanted pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pacemaker therapy	EVIA Pacemaker	-

Primary Outcome Measures

Name	Time	Method
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)	1 month follow-up completed	atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude.; atrial threshold test: measurable automatically or manually.

Secondary Outcome Measures

Name	Time	Method
Complication Free Rate	1- and 3- month follow-up completed	Complication free rate (in %): 1 minus(the number of possibly pacemaker related complications divided by the number of patients)

Trial Locations

Locations (1)

CHU Bordeaux Haut-Lévêque; 🇫🇷 Pessac, Bordeaux, France