RESponders and QUadripolar LV Lead in CRT

Heart Failure Clinical Trial

— ResQ CRT  

Official title:

Responders and Quadripolar LV Lead in CRT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02433756
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 29, 2015
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: Ospedale Santa Croce-Carle Cuneo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRTD

Locations

Country	Name	City	State
Italy	Ciriè Hospital	Ciriè
Italy	S.Croce e Carle Hospital	Cuneo
Italy	Maria Vittoria Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Croce-Carle Cuneo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months		6-Months	No
Primary	Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months		12-Months	No
Secondary	Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months		18 months	No