X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure

Phase 4TerminatedNCT00157846

Medtronic Cardiac Rhythm and Heart Failure36 enrolled

Overview

The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \< 35%). All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. The endpoint is functional performance measured by spiroergometry.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Heart Failure, Congestive

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Implanted dual-chamber pacemaker or ICD system with replacement indication * Because of battery end of life * Because of upgrade from pacemaker to ICD system * predominant sinus rhythm (paroxysmal atrial fibrillation \[AF\] \< 2 hours/day) * predominant ventricular stimulation (\>= 80%) * NYHA Class II-III * LVEF \<= 35% Exclusion Criteria: * NYHA Class IV * Life expectancy of less than one year because of accompanying diseases * Myocardial infarction less than 3 months old * Cardiac surgery less than 3 months * Bypass * Valve surgery * Percutaneous transluminal coronary angioplasty (PTCA) * Thoracotomy, for implant of an epicardial LV electrode * Medical circumstances that make participation and compliance impossible * Patients who are not willing or able to give written consent for their study participation * Participation in another study * Patients less than 18 years old * Pregnancy

Locations (10)

Klinikum Augsburg I. Medizinische Klinik

Augsburg, Germany

Charite Campus Virchow-Klinikum

Berlin, Germany

Unfallkrankenhaus Benjamin Franklin

Berlin, Germany

Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg

Bernau, Germany

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, Germany

Städtisches Kreiskrankenhaus

Friedrichshafen, Germany

Georg-August-Universität Göttingen

Göttingen, Germany

St.-Vincentius Klinken

Karlsruhe, Germany

Märkische Kliniken GmbH Klinikum Luedenscheid

Lüdenscheid, Germany

Krankenhaus Reinbek St. Adolf Stift

Reinbek B. Hamburg, Germany