The Effects of Anodal Stimulation on Echocardiographic Outcome in Patients With Cardiac Resynchronization Therapy

NCT ID: NCT00825006

Last Updated: 2009-01-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-12-31

Brief Summary

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To investigate the hemodynamic, inter and intraventricular desynchrony effects of anodal stimulation and triple site pacing compared with the usual dual site pacing by echocardiography and Tissue Doppler Imaging.

Detailed Description

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Thirty patients who underwent CRT and had evidence of anodal stimulation will be included in the study. All patients undergo a conventional echocardiography after 10 minutes of continuous triple site pacing and after 10 minutes of continuous dual site pacing (Customary biventricular pacing).Echocardiography studies will be performed to measure dP/dT using continuous flow Doppler velocity profiles of mitral regurgitation, LV volumes and Left ventricular ejection fraction. Left intraventricular desynchrony is assessed by using TDI.

Conditions

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Heart Failure

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Dual site pacing (LV tip electrode and RV tip electrode)

Group Type NO_INTERVENTION

No interventions assigned to this group

Triple site pacing

Triple site pacing(LV tip electrode,RV tip electrode and RV ring electrode)

Group Type EXPERIMENTAL

Triple site pacing mode

Intervention Type DEVICE

The experimental "Triple site pacing mode" includes pacing with Cardiac resynchronization therapy device using two leads; one in the right ventricle (RV) and one in the left ventricle (LV) but stimulates three sites: LV tip, RV tip and RV ring (instead of the usual two sites: LV tip and RV ring.

Patients with evidence of improved LV dyssinchrony parameters during the triple pacing mode (anodal stimulation) will be programmed to anodal stimulation for 3 months.

Interventions

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Triple site pacing mode

The experimental "Triple site pacing mode" includes pacing with Cardiac resynchronization therapy device using two leads; one in the right ventricle (RV) and one in the left ventricle (LV) but stimulates three sites: LV tip, RV tip and RV ring (instead of the usual two sites: LV tip and RV ring.

Patients with evidence of improved LV dyssinchrony parameters during the triple pacing mode (anodal stimulation) will be programmed to anodal stimulation for 3 months.

Intervention Type DEVICE

Other Intervention Names

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anodal stimulation, triple site pacing

Eligibility Criteria

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Inclusion Criteria

* Patients with biventricular pacemakers who met currently accepted indications for CRT, including dilated cardiomyopathy with LV ejection fraction \< 35% (ischemic and nonischemic etiologies) with New York Heart Association class III to IV congestive heart failure and QRS duration \> 120 ms.

Exclusion Criteria

* Patients with first generation CRT device
* Integrated bipolar defibrillator device
* Atrial fibrillation during the screening phase
* Patients who cannot tolerate triple site pacing for several minutes (i.e diaphragmatic pacing)
* Patients with epicardial LV leads
* Patients with LV leads located out of the lateral or posterolateral areas
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center, Heart Institute

Principal Investigators

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Michael Glikson, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute, Sheba Medical Center

Locations

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Heart Institute, Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michael Glikson, MD

Role: CONTACT

+97235302604

Alon Barsheshet, MD

Role: CONTACT

+97235302604

Facility Contacts

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Alon Barsheshet, MD

Role: primary

+97235302604

Other Identifiers

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SHEBA-08-5076-MG-CTIL

Identifier Type: -

Identifier Source: org_study_id

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