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

NCT ID: NCT01044784

Last Updated: 2020-07-08

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

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Schuchtermannklinik

Bad Rothenfelde, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24626999 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24263116 (View on PubMed)

Other Identifiers

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60028011

Identifier Type: -

Identifier Source: org_study_id

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