Reduction or Extension of COnduction Time With Ventricular Electromechanical Remodeling (RECOVER) (RECOVER)

June 29, 2021 updated by: Samsung Medical Center

Prospective Multicenter Observation Study on the Serial Changes in Ventriculo-ventricular Conduction Times According to Cardiac-resynchronization Therapy Response

This prospective multicenter registry study aims to detect the serial changes in ventriculo-ventricular conduction times according to cardiac-resynchronization therapy response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Sejong General Hospital
        • Contact:
          • Sang Weon Park
      • Changwon, Korea, Republic of
        • Recruiting
        • Samsung Changwon Medical Center
        • Contact:
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Jun-Hyung Kim
      • Daejeon, Korea, Republic of
        • Recruiting
        • Eulji University Hospital
        • Contact:
          • Ki-Woon Kang
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Il-young Oh
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients implanted with multipoint pacing CRT device and quadripolar left ventricular lead from Abbott

Description

Inclusion Criteria:

  • meeting the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for cardiac-resynchronization (CRT) implant

Exclusion Criteria:

  • Myocardial infarction, unstable angina within 40 days prior the enrollment
  • Recent cardiac revascularization in the 4 weeks prior to the enrollment or planned for the 3 months following
  • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months prior to the enrollment
  • Primary valvular disease requiring surgical correction
  • Pregnant or are planning during the duration of the investigation
  • Status 1 candidate for cardiac transplantation or consideration for transplantation over the next 12 months
  • Post-cardiac transplantation
  • Life expectancy < 12 months
  • Currently participating in any other clinical investigation except for observational registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRT responder
Diagnostic test: Device interrogation
Ventriculo-ventricular conduction time measurement using device analyzer
CRT non-responder
Diagnostic test: Device interrogation
Ventriculo-ventricular conduction time measurement using device analyzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serial change of ventriculo-ventricular conduction times
Time Frame: from enrollment to last follow-up (2 years)
Reduction or extension of ventriculo-ventricular conduction times
from enrollment to last follow-up (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2018

Primary Completion (Anticipated)

July 20, 2022

Study Completion (Anticipated)

July 20, 2024

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-05-073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Device interrogation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe