Multi-site Left Ventricular (MSLV) Pacing With Quartet 1458Q Lead

NCT ID: NCT01044472

Last Updated: 2019-02-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical investigation is to evaluate the safety and hemodynamic performance of the MSLV Pacing feature in a clinical setting.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the hemodynamic impact of different pacing MSLV configurations.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multi-site Left Ventricular Pacing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who have a recognised indication to receive a CRT-D device or an upgrade from a pacemaker or ICD to a CRT-D system.
* Patients have signed an informed consent form indicating their willingness to participate to this study.

Exclusion Criteria

* Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
* Patients with second or third degree AV Block
* Patients with intrinsic atrial rhythm \< 40 bpm
* Patients with a previously implanted left ventricular pacing lead.
* Patients who are pregnant.
* Patients currently participating in a clinical investigation that includes an active treatment arm.
* Patients under 18 years of age.
* Patients with a life expectancy of less then 6 months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Herzzentrum

Bad Krozingen, , Germany

Site Status

Kerckhoff - Klinik

Bad Nauheim, , Germany

Site Status

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, , Germany

Site Status

Schüchtermannklinik

Bad Rothenfelde, , Germany

Site Status

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt, , Germany

Site Status

Städt. Klinikum

Ludwigshafen, , Germany

Site Status

Klinikum Rosenheim

Rosenheim, , Germany

Site Status

Russells Hall

Dudley, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

St Thomas

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CR-09-048-EU-HF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.