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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
LV dp/dt pressure measurement
LV dp/dt pressure measurement
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Narrow QRS, CRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schuechtermann-Kliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CRT-ICD

DDD-ICD

Arm Description

Outcomes

Primary Outcome Measures

Indexed left ventricular volume

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2009
Last Updated
November 23, 2016
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00821938
Brief Title
Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Acronym
CRT-Narrow
Official Title
CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Narrow QRS, CRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT-ICD
Arm Type
Active Comparator
Arm Title
DDD-ICD
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
LV dp/dt pressure measurement
Intervention Description
Assessment of response to bi-ventricular pacing. Responder-arm, will be permanently paced bi-ventricularly
Intervention Type
Procedure
Intervention Name(s)
LV dp/dt pressure measurement
Intervention Description
Assessment of response to bi-ventricular pacing. Non-esponder-arm, will be treated with standard ICD-treatment
Primary Outcome Measure Information:
Title
Indexed left ventricular volume
Time Frame
12 months
Secondary Outcome Measure Information:
Title
NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Luedorff, MD
Organizational Affiliation
Schuechtermann-Kliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schuechtermann-Kliniken
City
Bad Rothenfelde
Country
Germany

12. IPD Sharing Statement

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

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