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Ventricular Pace Suppression Study (VpS)

B

Biotronik

Status

Completed

Conditions

Pacemaker Indication

Treatments

Device: VpS algorithm in EVIA and ENTOVIS pacemakers

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.

Full description

The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.

Enrollment

84 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Paroxysmal AV block and/or Sinus Node Dysfunction
  • DDD(R)-ADI(R)-Mode (VpS Algorithm) applicability

Exclusion criteria

  • Permanent AV block III°
  • Permanent Atrial Fibrillation/ Flutter
  • Require mode other than DDD(R)-ADI(R) or DDD(R)
  • Have a life expectancy of less than six months
  • Expected to receive heart surgery within six months
  • Enrolled in another cardiac investigation

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

84 participants in 2 patient groups

Ventricular Pace Suppression- ON
Other group
Treatment:
Device: VpS algorithm in EVIA and ENTOVIS pacemakers
Ventricular Pace Suppression- OFF
Other group
Treatment:
Device: VpS algorithm in EVIA and ENTOVIS pacemakers

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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