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

NCT00157846 | Terminated Phase 4

• 1 other identifier: CEN_G_CA_1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Heart Failure, Congestive

Keywords

Heart Failure; LVEF < 35%; Bradycardia

Outcome Measures

Primary Outcomes (1)

• Cardiopulmonary performance measured by spiroergometry

  Maximal oxygen uptake (Vo2 max \[ml/kg/min\])

  Baseline to 7 months post-implant

Secondary Outcomes (10)

• Left ventricular end diastolic diameter (LVEDD [mm])

  Baseline to 7 months post-implant

• N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml]

  Baseline to 7 months post-implant

• Left ventricular ejection fraction (LVEF [%])

  Baseline to 7 months post-implant

• New York Heart Association (NYHA) Class

  Baseline to 7 months post-implant

• Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day])

  Baseline to 7 months post-implant

Study Arms (2)

BiV Pacing

EXPERIMENTAL

Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months

Device: CRT-P or CRT-D Device

RV Stimulation

ACTIVE COMPARATOR

Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months

Device: CRT-P or CRT-D Device

Interventions

CRT-P or CRT-D Device DEVICE

Upgrade from ICD or pacemaker to CRT-D/CRT-P (Insync III, Insync Marquis, Insync Sentry, Insync Maximo, Concerto)

BiV Pacing; RV Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (10)

Klinikum Augsburg I. Medizinische Klinik

Augsburg, 86156, Germany

Location

Charite Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Unfallkrankenhaus Benjamin Franklin

Berlin, Germany

Location

Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg

Bernau, Germany

Location

Berufsgenossenschaftliche Kliniken Bergmannsheil

Bochum, 44789, Germany

Location

Städtisches Kreiskrankenhaus

Friedrichshafen, Germany

Location

Georg-August-Universität Göttingen

Göttingen, Germany

Location

St.-Vincentius Klinken

Karlsruhe, Germany

Location

Märkische Kliniken GmbH Klinikum Luedenscheid

Lüdenscheid, 58515, Germany

Location

Krankenhaus Reinbek St. Adolf Stift

Reinbek B. Hamburg, 21465, Germany

Location

MeSH Terms

Conditions

Heart Failure; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Lawo, MD

  Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: October 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 3, 2025

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)