NCT01365234

Brief Summary

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed. CRT is similar to a pacemaker. It is placed (implanted) under the skin of the upper chest. CRT is delivered as tiny electrical pulses to the right and left ventricles through three leads (flexible insulated wires) that are inserted through the veins to the heart. The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 heart-failure

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_1 heart-failure

Geographic Reach
3 countries

4 active sites

Status
completed

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

May 25, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4.4 years

First QC Date

May 25, 2011

Last Update Submit

October 10, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Number of implant procedure related and lead-related complications in the first month post-implant

    One Month

Secondary Outcomes (14)

  • Success rate of the Model 20066 lead

    Within 24 hours of procedure initiation

  • Cannulation time

    Within 24 hours of procedure initiation

  • Fluoroscopy Time

    Within 24 hours of procedure initiation

  • Model 20066 Lead Placement Time

    Within 24 hours of procedure initiation

  • Total Implant Time

    Within 24 hours of procedure initiation

  • +9 more secondary outcomes

Study Arms (1)

20066 Lead

EXPERIMENTAL

Non-randomized study. Intervention: Device: Pacing Lead

Device: Pacing Lead

Interventions

Pacing LeadDEVICE

Implant and follow up of Model 20066 lead

20066 Lead

Eligibility Criteria

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

You may qualify if:

  • Patient has signed and dated the study-specific informed consent form
  • Patient is 18 years of age or older
  • Patient is expected to remain available for follow-ups at the investigational center
  • Patient is willing and able to comply with protocol

You may not qualify if:

  • Patient has a previous complete atrial based biventricular CRT system
  • Patient has a previous LV lead implanted or previous implant attempt within 30 days of implant or ongoing Adverse Events from previous unsuccessful attempt
  • Patient has known coronary venous vasculature that is inadequate for lead placement
  • Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the past month
  • Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months
  • Patient has chronic (permanent) atrial arrhythmias
  • Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
  • Patient has had a heart transplant (patients waiting for heart transplants are allowed in the study)
  • Patient is enrolled in any concurrent drug and/or device study that may confound the results of this study
  • Patient has a terminal illness and is not expected to survive more than three months
  • Patient is unable to tolerate an urgent thoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

London, Canada

Location

Unknown Facility

Newmarket, Canada

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Stockholm, Sweden

Location

Related Publications (1)

  • Yee R, Gadler F, Hussin A, Bin Omar R, Khaykin Y, Verma A, Lazeroms M, Hine DS, Marquard KR. Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study. Heart Rhythm. 2014 Jul;11(7):1150-5. doi: 10.1016/j.hrthm.2014.04.020. Epub 2014 May 4.

    PMID: 24801899RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Raymond Yee, MD

    London Health Sciences Centre, London, Ontario, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 3, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

MY(1)CA(2)SE(1)