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Status unknownNCT02433756ResQ CRTUpdated Mar 31, 2016

RESponders and QUadripolar LV Lead in CRT

An observational study in Heart Failure, sponsored by Ospedale Santa Croce-Carle Cuneo. Status unknown at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-31.

Sponsored by Ospedale Santa Croce-Carle Cuneo · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.

Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.

To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.

After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).

After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).

02

Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 180 is close to the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Ospedale Santa Croce-Carle Cuneo is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart Failure

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
180 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Interventions

  • DeviceCRTD
06

What researchers measure

Primary outcomes

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

    Time frame: 6-Months

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

    Time frame: 12-Months

Secondary outcomes

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

    Time frame: 18 months

07

Study locations

3 of 3 sites recruiting
  • Ciriè Hospital
    Cirié, Italy
    Recruiting
  • S.Croce e Carle Hospital
    Cuneo, Italy
    Recruiting
  • Maria Vittoria Hospital
    Torino, Italy
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Mar 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2015
First posted
May 5, 2015
Start
Mar 2013
Primary completionActual
Mar 2016
CompletionEst.
May 2016
Last update
Mar 31, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02433756
Lead sponsor
Ospedale Santa Croce-Carle Cuneo
Responsible party
Antonello Vado (MD, Ospedale Santa Croce-Carle Cuneo) — Principal investigator
First posted
May 5, 2015
Start date
Mar 2013
Primary completion
Mar 2016
Completion
May 2016 (estimated)
Last update
Mar 31, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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