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

NCT02374801 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-01-11

No results posted yet for this study

Summary

The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance 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 a patient population that is reflective of current heart failure treatment practice.

Conditions

  • Heart Failure (NYHA Class III and Ambulatory IV)

Interventions

DEVICE

SonR automatic optimization feature turned ON ("AV+VV").

Sponsors & Collaborators

  • Sorin CRM

    collaborator UNKNOWN

  • MicroPort CRM

    lead INDUSTRY

Principal Investigators

  • Jagmeet P. Singh, M.D. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-04-30
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

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 NCT02374801 on ClinicalTrials.gov