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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04397224
• Collaborator: Abbott Medical Devices (Industry)
• Enrollment: 100
• Locations: 6
• Anticipated Duration (Months): 72
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Diagnostic Test: Device interrogation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Multicenter Observation Study on the Serial Changes in Ventriculo-ventricular Conduction Times According to Cardiac-resynchronization Therapy Response
• Actual Study Start Date: Jul 20, 2018
• Anticipated Primary Completion Date: Jul 20, 2022
• Anticipated Study Completion Date: Jul 20, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Serial change of ventriculo-ventricular conduction times [from enrollment to last follow-up (2 years)]

   Reduction or extension of ventriculo-ventricular conduction times

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sejong General Hospital	Bucheon		Korea, Republic of
2	Samsung Changwon Medical Center	Changwon		Korea, Republic of
3	Chungnam National University Hospital	Daejeon		Korea, Republic of
4	Eulji University Hospital	Daejeon		Korea, Republic of
5	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
6	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04397224
• Other Study ID Numbers: 2018-05-073
• First Posted: May 21, 2020
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Jun 30, 2021