NCT02433756

Brief Summary

The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.

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
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

March 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

April 22, 2015

Last Update Submit

March 29, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months

    6-Months

  • Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months

    12-Months

Secondary Outcomes (1)

  • Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months

    18 months

Interventions

CRTDDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart Failure

You may qualify if:

  • Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines
  • Successful quadripolar LV lead implant

You may not qualify if:

  • Less than 18 years of age
  • Epicardial Lead
  • Life expectancy \< 12 months
  • Pregnant or are planning to become pregnant during the duration of the investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ciriè Hospital

Cirié, Italy

RECRUITING

S.Croce e Carle Hospital

Cuneo, Italy

RECRUITING

Maria Vittoria Hospital

Torino, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 5, 2015

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

IT(3)