NCT00819117

Brief Summary

The purpose of this study is to demonstrate that epicardial and transvenous left ventricular leads are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a CRT device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.9 years

First QC Date

January 7, 2009

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Keywords

Epicardial leadsCardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (1)

  • The efficacy will be evaluated by comparing the pacing thresholds at 6 months between the two groups. The safety will be evaluated by comparing the survival from lead-related complications at 6 months between the two groups.

    6 months follow up after implant

Study Arms (2)

Transvenous Lead (TVN CRT)

ACTIVE COMPARATOR

Control group: resynchronization via a transvenous left ventricular lead (TVN CRT)

Device: Cardiac Resynchronization Therapy implant

Epicardial Lead (EPI CRT)

EXPERIMENTAL

Treatment group: resynchronization via an epicardial left ventricular lead (EPI CRT)

Device: Cardiac Resynchronization Therapy implant

Interventions

Cardiac Resynchronization Therapy implantDEVICE

Device implant with appropriate leads

Epicardial Lead (EPI CRT)Transvenous Lead (TVN CRT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have an approved indication for implantation of an CRT device (ESC guidelines , including any update);
  • Have a stable pharmacological therapy.

You may not qualify if:

  • Have a contra-indication to general anesthesia;
  • Have a scheduled cardiac surgery;
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment;
  • Have a life expectancy of less than 6 months;
  • Are unable to provide informed consent;
  • Are unable to comply with the follow-up schedule and tests;
  • Are minor (age below 18 years);
  • Are pregnant or are planning for pregnancy in the next 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale Cisanello

Pisa, 56126, Italy

Location

Azienda Sanitaria Osperaliera Ordine Mauriziano

Torino, 10128, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Maria Grazia Bongiorni, MD

    Ospedale Cisanello, Pisa, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2009

First Posted

January 8, 2009

Study Start

November 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

IT(2)