NCT00746135

Brief Summary

It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2007

Longer than P75 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

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

August 20, 2008

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Keywords

Heart failure (NYHA class III and IV)Ventricular Dyssynchrony

Outcome Measures

Primary Outcomes (1)

  • Improvement according to Packer's "Heart Failure Clinical Composite Respond"

    12 months post implant

Secondary Outcomes (8)

  • Intraoperative Increase in Left Ventricular dp/dt

    At Implant

  • Cardiopulmonary Capacity(Spiroergometry)

    12 months

  • Change in B-type natriuretic Peptide (BNP)-Concentration

    12 months

  • 6 min walk test

    12 months

  • QoL assessment("Minnesota Living with Heart Failure = MLHF)

    12 months

  • +3 more secondary outcomes

Study Arms (3)

A

ACTIVE COMPARATOR

Conventional Biventricular Stimulation: RV Apex and LV Lead Tip

Device: Device Implantation

B

ACTIVE COMPARATOR

Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".

Device: Device Implantation

C

ACTIVE COMPARATOR

Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His

Device: Device Implantation

Interventions

Device ImplantationDEVICE

RV apical pacing lead, RV pacing lead at HIS bundle position, LV pacing lead implantation

Also known as: CRT-D Devices:, Atlas™ II+ HF / V-367 /St. Jude Medical, Epic™ II+ HF / V-357 / St. Jude Medical, Promote™ / 3207-36 / 3213-36 / St. Jude Medical, Adapters:, VIS 16 / Dr. Osypka GmbH
ABC

Eligibility Criteria

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

You may qualify if:

  • Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
  • LVEDD \> 55 mm or \> 30 mm/m² BSA
  • EF \< 35%
  • Sinus rhythm and one of the following criteria:
  • QRS \>= 120 ms and PQ \>= 200ms
  • nd / 3rd degree AV block
  • Written informed consent

You may not qualify if:

  • pacemaker indication (without ICD indication)
  • tricuspidal valve and/or aortic valve replacement
  • Indication for revascularization.
  • less than 3 month after heart surgery or myocardial infarction
  • hypertrophic obstructive cardiomyopathy
  • intravenous catecholamine treatment
  • uncorrected thyroid function
  • severe kidney disorder (creatinin \>2,5mg%)
  • no written patient consent
  • insufficient patient compliance
  • participating in another study
  • life expectancy \< 1 year due to other severe disease
  • age \< 18 years
  • no contraception (young women) or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde

Bad Rothenfelde, 49214, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Wolfgang Kranig, MD

    Departement of Cardiology - Electrophysiology- Heart Centre Osnabrück - Bad Rothenfelde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

September 3, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2012

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

DE(1)