Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony

Acute Evaluation of the Safety of LV-LV Delays and Its Effects on Mechanical Dyssynchrony

The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.

Study Overview

• Status: Completed
• Conditions: Cardiac Resynchronization Therapy

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Germany
  • Bad Rothenfelde, Germany
    • Schuchtermannklinik

Participation Criteria

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

Patients indicated for standard CRT-D indications.

Description

Inclusion Criteria:

1. Have an approved indication for a CRT implant
2. Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site
3. Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations

Exclusion Criteria:

1. Have persistent or permanent atrial fibrillation
2. Have an intrinsic heart rate of <50 beats per minute
3. Have Cheyne-Stokes breathing
4. Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
5. Have had a recent CVA or TIA within 3 months prior to enrollment
6. Be less than 18 years of age
7. Be pregnant

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Publications and helpful links

General Publications

• Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14.
• Rinaldi CA, Kranig W, Leclercq C, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Acute effects of multisite left ventricular pacing on mechanical dyssynchrony in patients receiving cardiac resynchronization therapy. J Card Fail. 2013 Nov;19(11):731-8. doi: 10.1016/j.cardfail.2013.10.003. Epub 2013 Oct 10. Erratum In: J Card Fail. 2014 May;20(5):376.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 7, 2010
• First Posted (Estimate): January 8, 2010

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: CRT
• Other Study ID Numbers: 60028011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No