NCT00821938

Brief Summary

Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4 heart-failure

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_4 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

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 3, 2025

Status Verified

November 1, 2016

Enrollment Period

3.7 years

First QC Date

January 13, 2009

Last Update Submit

June 30, 2025

Conditions

Heart Failure

Keywords

Narrow QRSCRT

Outcome Measures

Primary Outcomes (1)

  • Indexed left ventricular volume

    12 months

Secondary Outcomes (1)

  • NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria

    12 months

Study Arms (2)

CRT-ICD

ACTIVE COMPARATOR
Procedure: LV dp/dt pressure measurement

DDD-ICD

PLACEBO COMPARATOR
Procedure: LV dp/dt pressure measurement

Interventions

LV dp/dt pressure measurementPROCEDURE

Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly

CRT-ICD

Eligibility Criteria

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

You may qualify if:

  • EF \< 35%
  • CHD or dilate cardiomyopathy
  • sinus rhythm
  • NYHA III (or IV but stable recompenstated)
  • QRS \< 120 ms 2-3 of the following:
  • LV-fillingtime \< 40% of the cyclelength
  • TDI septal-lateral (LV basal) \> 60ms
  • D-Strain-Score \> 9 points

You may not qualify if:

  • tricuspid or artificial valve
  • AV block II or III or PQ time \> 250ms
  • revasculisation or condition after cardiac surgery \< 3 months
  • myocardial infarction or bypass OP \< 3 months
  • hytertrphic obstructive cardiomyopathy, constrictive pericarditis
  • intravenous catecholamines because of HF
  • manifeste hyperthyreoses
  • kidney failure (creatine \>2,5 mg/dl)
  • no written informed consent
  • no compliance
  • participation in another study
  • life expectancy \< 1 year
  • patients \< 18 years
  • pragnancy or no safe contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schuechtermann-Kliniken

Bad Rothenfelde, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Guido Luedorff, MD

    Schuechtermann-Kliniken

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

November 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2016

Last Updated

July 3, 2025

Record last verified: 2016-11

Locations

DE(1)