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NCT02167789 · ClinicalTrials.gov registry record · Phase 3

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

A Phase 3 study of Heart Failure, sponsored by LivaNova.

Completed
Registry status
Phase 3
Development phase
520
Enrollment target
20
Study locations

NCT02167789 is a Phase 3 study of Heart Failure that has completed, run by LivaNova. The registered enrollment target is 520 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02167789, a Phase 3 study of Heart Failure, has completed, sponsored by LivaNova.

COMPLETED
Registry status
Phase 3
Development phase
520 participants
Enrollment target
20
Study locations

Study Summary

This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

Conditions Studied

Interventions

  • DEVICE Paradym CRT 8770

Study Locations (20)

Arizona

  • Dr. Haines - Kaplan, Phoenix,
  • Drs. Lewis, Garg - Siegel, Phoenix,

Quebec

  • Dr. Champagne, Dr. Philippon - Québec
  • Drs. Thibualt, Guerra - Québec

Nantes

  • Dr. Burban - Nantes
  • Dr Abbey - Nantes

Massachusetts

  • Drs. Jagmeet Singh, Kevin, Hiest - Boston

New York

  • Drs. John Fisher, Jay Gross - Montefiore, Bronx NY

South Carolina

  • Dr. Gold - Charleston

Angers

  • Dr. Dupuis - Angers

Grenoble

  • Dr. Defaye - Grenoble

Trial Details

FieldValue
Enrollment Target 520 participants
Start Date 2009-09
Est. Completion 2013-06
Phase Phase 3

Sponsor

LivaNova

13 total trials

What the Registry Record Tells You About NCT02167789

The ClinicalTrials.gov registry entry for NCT02167789 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (75% lower). The listed sponsor is LivaNova, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Paradym CRT 8770 is the first listed.

NCT02167789 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Arizona, Quebec, Nantes.

Frequently Asked Questions

What is clinical trial NCT02167789 about?

NCT02167789 is a clinical study titled "Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device". This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

What is the current status of trial NCT02167789?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 520 participants. The study started on 2009-09. Estimated completion is 2013-06.

What conditions does trial NCT02167789 study?

This clinical trial studies the following conditions: Heart Failure.

What interventions are being tested in trial NCT02167789?

The interventions under investigation include: Paradym CRT 8770 (DEVICE).

Who is sponsoring clinical trial NCT02167789?

This trial is sponsored by LivaNova, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02167789 being conducted?

This trial has 20 study locations across Arizona, Massachusetts, New York, South Carolina, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.