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

Heart Failure Clinical Trial

— RECOVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04397224
• Other study ID #: 2018-05-073
• Status: Recruiting
• Start date: July 20, 2018
• Est. completion date: July 20, 2024

Study information

• Verified date: June 2021
• Source: Samsung Medical Center
• Contact: Seung-Jung Park
• Phone: +82-2-3410-7145
• Email: orthovics[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Device interrogation
Ventriculo-ventricular conduction time measurement using device analyzer

Locations

Country	Name	City	State
Korea, Republic of	Sejong General Hospital	Bucheon
Korea, Republic of	Samsung Changwon Medical Center	Changwon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Abbott Medical Devices

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial change of ventriculo-ventricular conduction times	Reduction or extension of ventriculo-ventricular conduction times	from enrollment to last follow-up (2 years)