RESponders and QUadripolar LV Lead in CRT

NCT ID: NCT02433756

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CRTD

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Santa Croce-Carle Cuneo

OTHER

Sponsor Role lead

Responsible Party

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Antonello Vado

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ciriè Hospital

Cirié, , Italy

Site Status RECRUITING

S.Croce e Carle Hospital

Cuneo, , Italy

Site Status RECRUITING

Maria Vittoria Hospital

Torino, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Gaetano Senatore

Role: primary

Antonello Vado

Role: primary

Massimo Giammaria

Role: primary

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id