TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study

NCT ID: NCT00746135

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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A

Conventional Biventricular Stimulation: RV Apex and LV Lead Tip

Group Type ACTIVE_COMPARATOR

Device Implantation

Intervention Type DEVICE

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

B

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

Group Type ACTIVE_COMPARATOR

Device Implantation

Intervention Type DEVICE

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

C

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

Group Type ACTIVE_COMPARATOR

Device Implantation

Intervention Type DEVICE

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

Interventions

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Device Implantation

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

Intervention Type DEVICE

Other Intervention Names

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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

Eligibility Criteria

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Inclusion Criteria

* 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
* or
* 2nd / 3rd degree AV block
* Written informed consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Kranig, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bad Rothenfelde, , Germany

Site Status

Countries

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Germany

Other Identifiers

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H37

Identifier Type: -

Identifier Source: org_study_id

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