Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study | NCT00821938

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

NCT00821938

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Heart Failure

Interventions

LV dp/dt pressure measurement
LV dp/dt pressure measurement

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jan 13, 2009

First Submission Date that Met QC Criteria

Jan 13, 2009

First Posted Date

Jan 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2025

Last Update Posted Date

Jul 3, 2025Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CRT-ICD	Active Comparator		Procedure: LV dp/dt pressure measurement
DDD-ICD	Placebo Comparator		Procedure: LV dp/dt pressure measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LV dp/dt pressure measurement	Procedure	Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly	CRT-ICD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Indexed left ventricular volume		12 months

Secondary Outcomes

Measure	Description	Time Frame
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guido Luedorff, MD	Schuechtermann-Kliniken	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schuechtermann-Kliniken		Bad Rothenfelde			Germany

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided