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Biventricular Tachycardias Outcome Trial

NCT00729235 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2011-12-22

No results posted yet for this study

Summary

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.

The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.

All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

* Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
* VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.

The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.

Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

Conditions

  • Biventricular Tachycardias

Interventions

DEVICE

Ovatio CRT 6750

Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)

DEVICE

Ovatio CRT 6750

Slow VT zone programmed with ATP therapies (therapy arm).

Sponsors & Collaborators

  • LivaNova

    lead INDUSTRY

Principal Investigators

  • Alexander Bauer · Universitätsklinikum Heidelberg, 69120 Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-12-31
Completion
2011-11-30

Countries

  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00729235 on ClinicalTrials.gov