ResQ CRT: RESponders and QUadripolar LV Lead in CRT

• Sponsor: Ospedale Santa Croce-Carle Cuneo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02433756
• Collaborator: (none)
• Enrollment: 180
• Locations: 3
• Duration (Months): 38
• Patients Per Site: 60
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: CRTD

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 180 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Responders and Quadripolar LV Lead in CRT
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Anticipated Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ciriè Hospital	Ciriè		Italy
2	S.Croce e Carle Hospital	Cuneo		Italy
3	Maria Vittoria Hospital	Torino		Italy

Sponsors and Collaborators

• Ospedale Santa Croce-Carle Cuneo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonello Vado, MD, Ospedale Santa Croce-Carle Cuneo
• ClinicalTrials.gov Identifier: NCT02433756
• Other Study ID Numbers: 001
• First Posted: May 5, 2015
• Last Update Posted: Mar 31, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Mar 31, 2016