NCT01429753

Brief Summary

Cardiac resynchronisation therapy (CRT) is an established treatment for improving symptoms in patients with congestive heart failure (CHF) by left ventricular (LV) pacing. CRT can help to improve LV function in patients with heart failure if those regions of the myocardium which are most compromised by electromechanical dyssynchrony can be identified and effectively stimulated. There still remains, however, a significant rate of up to 30% of patients who do not respond to treatment. Reasons for lack of benefit can be related to the inability of identifying and effectively stimulating those regions of myocardium, which are most compromised by electromechanical dyssynchrony. The investigators hypothesize that by using cardiac MR and 3D echo to identify scar, reconstruct coronary sinus anatomy, and determine the site of latest LV activation, the investigators can find the best place to implant the left ventricular lead. By avoiding scar and pacing in the site of latest activation, the investigators believe the investigators will reduce dyssynchrony and thus improve overall heart function. The researchers thus aim to increase the proportion of people who respond to treatment. The researchers also believe that the procedure may be streamlined so as to reduce procedure duration, radiation dose and dose of iodinated contrast medium.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for phase_2 heart-failure

Timeline
Completed

Started Oct 2011

Typical duration for phase_2 heart-failure

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

First Submitted

Initial submission to the registry

September 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

2.5 years

First QC Date

September 5, 2011

Last Update Submit

September 6, 2011

Conditions

Heart Failure

Keywords

Cardiac resychronisation therapyHeart failureImaging guided LV lead placement

Outcome Measures

Primary Outcomes (1)

  • Change in the proportion of CRT responders

    6 months

Secondary Outcomes (7)

  • Change in echo derived end systolic (ESV) and diastolic volumes

    6 months

  • Six month assessment of change in 6 minute walk distance and VO2 max (CPEX)

    6 months

  • Procedural success

    0 months

  • Procedure duration

    0 months

  • Radiation dose

    0 months

  • +2 more secondary outcomes

Study Arms (2)

Standard LV lead placement

ACTIVE COMPARATOR
Device: Standard LV lead placement

Advanced Imaging Guided LV Lead Placement

EXPERIMENTAL
Other: Advanced Imaging Guided LV lead placement

Interventions

Advanced Imaging Guided LV lead placementOTHER

Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.

Advanced Imaging Guided LV Lead Placement
Standard LV lead placementDEVICE

Standard LV lead placement not guided by advanced imaging

Standard LV lead placement

Eligibility Criteria

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

You may qualify if:

  • \>18yrs of age
  • Standard indication for CRT=P or CRT=D according to NICE criteria (Clinical symptoms of heart failure despite medical therapy, broad QRS \>120ms and significant LV dysfunction LEF \<35%)
  • Stable on optimal medical therapy for at least 3 months
  • Ischaemic or non-ischaemic aetiology

You may not qualify if:

  • Any contraindication to pacing /ICD implant
  • Contraindication to MR scanning
  • Claustrophobia
  • Significant renal impairment (estimated GFR \<30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christopher Aldo Rinaldi, MD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manav Sohal, MBBS

CONTACT

+442071887188manav.sohal@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Fellow

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 7, 2011

Study Start

October 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 7, 2011

Record last verified: 2011-09