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Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination

NCT01410552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1013

Last updated 2019-03-22

Study results available
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Summary

ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

Conditions

  • Tachycardia

Interventions

DEVICE

PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770

PARADYM ICD and CRT-d with PARAD+ algorithm available

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Ricardo RUIZ GRANELL, Dr · Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN

  • Mark RICHARDS, Dr. · Toledo Hospital, 4614 Brookside Dr. Toledo (OH)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-08-31
Completion
2016-02-29

Countries

  • United States
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • 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 NCT01410552 on ClinicalTrials.gov