Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

Safety from major complications post device implants & procedures
Freedom from major complications following device implants and procedures, whether single stage or multiple staged procedures. Major complications are defined as any complication related to the device or procedure that results in death, hospitalization, prolongation of hospitalisation for 48 or more hours, permanent loss of device function due to a mechanical or electrical malfunction or system change (removal, repositioning, or replacement).
6 months
Efficacy of Cardiac Resynchronisation Therapy (CRT) measured by confirmation of Bi Ventricular Pacing on 12 lead ECG.
Evidence of biventricular pacing on 12 lead ECG recorded at 6 months will confirm CRT delivered by implanted devices for each participant.
6 months

Secondary Outcomes (4)

Clinical Response of Each Participant measuring Left Ventricular Ejection Fraction.
6 months
Clinical Response of Each Participant measuring Left Ventricular End Systolic Volume.
6 months
Clinical response of Each Participant measuring New York Heart Association classification.
6 months
Clinical response of Each Participant measuring 6 Minute Walk Test
6 months

Other Outcomes (1)

Analysis of single stage and multiple stage device implant procedure times
6 months

Interventions

Implant of WiSE-CRT with intracardiac pacemakerDevice

Implant of two cardiac devices

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult patients appropriate for these devices

You may qualify if:

Male or Female, aged 18 years or above. Participant is willing and able to give informed consent for participation in the study.

Sponsors & Collaborators

University Hospital Southampton NHS Foundation Trust
Otherlead
EBR Systems, Inc.
Industrycollaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Paul R Roberts, MD
University Hospital Southampton NHS Foundation Trust
PRINCIPAL INVESTIGATOR

Central Study Contacts

elizabeth greenwood, MSc

CONTACT

023 8120 8646 elizabeth.greenwood@uhs.nhs.uk

elizabeth greenwood, MSc

CONTACT

023 8120 8646

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 12, 2022

First Posted

July 11, 2022

Study Start

July 1, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2025

Estimated (date passed)

Implant of the WiSE CRT System With an Intracardiac Pacemaker

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record