RESponders and QUadripolar LV Lead in CRT (ResQ CRT)

March 29, 2016 updated by: Antonello Vado, Ospedale Santa Croce-Carle Cuneo

Responders and Quadripolar LV Lead in CRT

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ciriè, Italy
      • Cuneo, Italy
        • Recruiting
        • S.Croce e Carle Hospital
        • Contact:
      • Torino, Italy
        • Recruiting
        • Maria Vittoria Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart Failure

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
Time Frame: 6-Months
6-Months
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months
Time Frame: 12-Months
12-Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Croce-Carle Cuneo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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