Characterization of Cardiac Hemodynamics During MultiSite Pacing

NCT ID: NCT01564186

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MulitPoint Pacing

No interventions assigned to this group

BiV Conventional

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines
• Be in sinus rhythm at the time of enrollment
• Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria

• Exhibit Cheyne-Stokes respiration
• Have persistent or permanent atrial fibrillation
• Have complete heart block
• Be in NYHA IV functional class
• Have a recent myocardial infarction within 40 days prior to enrollment
• Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
• Have had a recent CVA or TIA within 3 months prior to enrollment
• Have had intravenous inotropic support in the last 30 days
• Be less than 18 years of age
• Be pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

Maria Cecilia Hospital

Locations

Maria Cecilia Hospital

Cotignola, , Italy

Countries

Italy

References

Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Jordan CD, Romano E, Baldi M, Saviano M, Pappone A, Vitale R, Catalano C, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Fragakis N, Fundaliotis A, Tavazzi L, Santinelli V. Improving cardiac resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. Heart Rhythm. 2015 Jun;12(6):1250-8. doi: 10.1016/j.hrthm.2015.02.008. Epub 2015 Feb 9.

Reference Type: DERIVED

PMID: 25678057 (View on PubMed)

Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Baldi M, Saviano M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing in a single coronary sinus branch improves mid-term echocardiographic and clinical response to cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2015 Jan;26(1):58-63. doi: 10.1111/jce.12513. Epub 2014 Sep 19.

Reference Type: DERIVED

PMID: 25109276 (View on PubMed)

Other Identifiers

643

Identifier Type: -

Identifier Source: org_study_id