NCT00764075

Brief Summary

In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

2.5 years

First QC Date

September 26, 2008

Last Update Submit

July 6, 2011

Conditions

Heart Failure

Keywords

heart failure; EF<35%; NYHA II, III or IV

Outcome Measures

Primary Outcomes (1)

  • Rate of non-responders regarding ejection fraction

    6 months

Secondary Outcomes (1)

  • rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume

    6 months

Study Arms (3)

1

EXPERIMENTAL

guided implantation of the left ventricular lead

Device: Beutel TM

2

PLACEBO COMPARATOR

standard implantation of the left ventricular lead

Other: standard

Pilot Group

EXPERIMENTAL

feasibility of guided placement of CRT-leads in 20 Patients

Device: software Beutel TM

Interventions

Beutel TMDEVICE

application of BeutelTM

1
standardOTHER

standard procedure will be applied but no Beutel TM software

2
software Beutel TMDEVICE

application of BeutelTM to patients data for determination of site of latest contraction

Pilot Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Congestive heart failure,
  • Ejection fraction \<35%,
  • Complete left bundle branch block \>120ms,
  • NYHA II,III or IV

You may not qualify if:

  • Impaired kidney function (GFR \<30ml/min;
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christian Knackstedt, MD

    RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2008

First Posted

October 1, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

DE(1)