ECOST-CRT: Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03012490
• Collaborator: Biotronik France (Industry)
• Enrollment: 652
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 61.1
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Cardiac Resynchronization Therapy	Other: CRT-P or CRT-D standard remote monitoring; Other: CRT-P or CRT-D full remote monitoring; Other: Symptoms and signs remote monitoring	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 652 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy
• Actual Study Start Date: Feb 27, 2017
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard remote monitoring Remote monitoring of CRT-P and CRT-D is activated. The physician will only receive the notifications related to technical events and ventricular arrhythmias. Therapy will be added or changed in response to these notifications and/or the symptoms and signs observed during ambulatory visits.	Other: CRT-P or CRT-D standard remote monitoring; standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system
Experimental: Comprehensive remote monitoring Remote monitoring of CRT-P and CRT-D is activated, as well as remote assessment of symptoms and signs. In addition to notifications related to technical events and ventricular arrhythmias, the physician will receive notifications related to heart failure parameters, atrial arrhythmias, and patient's symptoms and signs. Therapy will be added or changed in response to these notifications, and/or to the symptoms and signs observed during ambulatory visits.	Other: CRT-P or CRT-D standard remote monitoring; standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system; Other: CRT-P or CRT-D full remote monitoring; Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient; Other: Symptoms and signs remote monitoring; symptoms and clinical signs of the patient

Outcome Measures

Primary Outcome Measures

1. composite criteria including death from any cause and hospitalization for worsening HF [during the 27 months follow-up]

Secondary Outcome Measures

1. Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs [27 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient more than 18 years old, newly implanted, in accordance to the latest European guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device replacement), with Home-Monitoring® activated

• Patient willing and able to comply with the protocol and who has provided written informed consent

Exclusion Criteria:

• Lead model under advisory

• Non-functional lead except particular case of non-functional or deactivated right atrial lead due to atrial fibrillation

• Known drug or alcohol abuse

• Pregnant woman or woman who plan to become pregnant during the trial (the data will be collected by querying the patient without a pregnancy test is required)

• Participation (ongoing or planned during the trial) in another interventional clinical study, and/or another remote monitoring and/or follow-up concept, unless authorized by the Executive Committee

• Participation (ongoing or planned during the trial) in an investigational HF program (e.g. PRADO, PIMPS, OSICAT, CARDIAUVERGNE)

• Estimated life-expectancy, regardless of the cardiovascular condition, <1year

• Patient under- or planned for - ventricular assistance

• Patient not living in Metropolitan France and/or not geographically stable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut coeur poumon, CHRU	Lille		France

Sponsors and Collaborators

• University Hospital, Lille
• Biotronik France

Investigators

• Principal Investigator: Laurence Guedon-Moreau, MD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03012490
• Other Study ID Numbers: 2016_03; 2016-A00873-48
• First Posted: Jan 6, 2017
• Last Update Posted: Aug 27, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Lille: Remote monitoring
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Aug 27, 2020