NCT02529410

Brief Summary

100 pt multicentre study 50 pts randomised to triventricular pacemaker, 50 to biventricular pacemaker Feasibility study with 6 month outcome data

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

August 17, 2015

Last Update Submit

February 29, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Feasibility of achieving and maintaining triventricular pacing at 6 months

    Percentage of patients having triventricular pacing at 6 months

    6 months

Secondary Outcomes (9)

  • Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15%

    6 months

  • Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume )

    6 months

  • Proportion of patients who successfully reverse remodel as per echo (success being defined as a reduction in end systolic volume of > 15% with prespecified subgroups (AF and aetiology)

    6 months

  • Proportionate effect of intervention and comparator with regard to reverse remodelling (comparison of % reduction in left ventricular end systolic volume ) (AF and aetiology)

    6 months

  • Mean change in Nt proBNP in patients with triventricular devices compared with biventricular devices (pg/ml)

    6 months

  • +4 more secondary outcomes

Study Arms (2)

Triventricular pacing

EXPERIMENTAL

2 Left ventricular leads and one right ventricular lead

Procedure: Cardiac Resynchronisation Therapy

Biventricular leads

ACTIVE COMPARATOR

1 left ventricular lead and one right ventricular lead

Procedure: Cardiac Resynchronisation Therapy

Interventions

Cardiac Resynchronisation TherapyPROCEDURE
Also known as: Cardiac Resynchronisation Therapy with Defibrillator
Biventricular leadsTriventricular pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Class 1b Indication for CRT (LBBB QRS120-150ms) as per ESC guidelines 2013
  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

  • Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Insufficient capacity to consent to the study
  • QRS \>150ms and Non-LBBB morphology 120-150ms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas Hospital Trust

London, Se1 7EH, United Kingdom

RECRUITING

Related Publications (1)

  • Gould J, Claridge S, Jackson T, Sieniewicz BJ, Sidhu BS, Porter B, Elliott MK, Mehta V, Niederer S, Chadwick H, Kamdar R, Adhya S, Patel N, Hamid S, Rogers D, Nicolson W, Chan CF, Whinnett Z, Murgatroyd F, Lambiase PD, Rinaldi CA. Standard care vs. TRIVEntricular pacing in Heart Failure (STRIVE HF): a prospective multicentre randomized controlled trial of triventricular pacing vs. conventional biventricular pacing in patients with heart failure and intermediate QRS left bundle branch block. Europace. 2022 May 3;24(5):796-806. doi: 10.1093/europace/euab267.

    PMID: 35079787DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization TherapyDefibrillators

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeuticsElectrodesElectrical Equipment and SuppliesEquipment and Supplies

Central Study Contacts

Simon Claridge, MBBS

CONTACT

02071887188simon.claridge@kcl.ac.uk

Aldo Rinaldi, MD

CONTACT

aldo.rinaldi@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 20, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

GB(1)