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Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

NCT01534234 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1039

Last updated 2019-01-11

No results posted yet for this study

Summary

The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

Conditions

  • Heart Failure NYHA Class III and Ambulatory IV

Interventions

DEVICE

PARADYM RF SONR

SonR CRT Optimization

DEVICE

PARADYM RF SONR

Echocardiography Optimization

Sponsors & Collaborators

  • Sorin CRM

    collaborator UNKNOWN

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Josep Brugada · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Slovenia
  • Spain
  • Switzerland
  • 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 NCT01534234 on ClinicalTrials.gov