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Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study

CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00821938
Acronym
CRT-Narrow
Enrollment
30
Registered
2009-01-14
Start date
2008-11-30
Completion date
2016-07-31
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Narrow QRS, CRT

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

Interventions

PROCEDURELV dp/dt pressure measurement

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

Sponsors

Medtronic
CollaboratorINDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 2D-Strain-Score \> 9 points

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Indexed left ventricular volume12 months

Secondary

MeasureTime frame
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026