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Heart Failure, CongestivePhase 4NCT00157846

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

A Phase 4 study testing CRT-P or CRT-D Device in people with Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
CRT-P or CRT-D Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
10 sitesGermany
Study dates
Oct 2003to Aug 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • Klinikum Augsburg I. Medizinische Klinik

    Augsburg, 86156

  • Charite Campus Virchow-Klinikum

    Berlin, 13353

  • Unfallkrankenhaus Benjamin Franklin

    Berlin

  • Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg

    Bernau

  • Berufsgenossenschaftliche Kliniken Bergmannsheil

    Bochum, 44789

  • Städtisches Kreiskrankenhaus

    Friedrichshafen

  • Georg-August-Universität Göttingen

    Göttingen

  • St.-Vincentius Klinken

    Karlsruhe

  • Märkische Kliniken GmbH Klinikum Luedenscheid

    Lüdenscheid, 58515

  • Krankenhaus Reinbek St. Adolf Stift

    Reinbek B. Hamburg, 21465

Other trials in Germany

About this study

Official title: Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation

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.

Being tested
CRT-P or CRT-D Device
Keywords
Heart Failure, LVEF < 35%, Bradycardia
Medical subject headings
Heart Failure, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRT-P or CRT-D DeviceDevice

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

Study groups in NCT00157846
Study groupRoleWhat they receive
BiV PacingExperimentalBiventricular pacing for 3 months, subsequently right ventricular pacing for 3 months
Receives: Device: CRT-P or CRT-D Device
RV StimulationActive comparatorRight ventricular pacing for 3 months, subsequently biventricular pacing for 3 months
Receives: Device: CRT-P or CRT-D Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiopulmonary performance measured by spiroergometry

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

    Measured: Baseline to 7 months post-implant

Secondary outcomes (10)

  1. Left ventricular end diastolic diameter (LVEDD [mm])

    Measured: Baseline to 7 months post-implant

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

    Measured: Baseline to 7 months post-implant

  3. Left ventricular ejection fraction (LVEF [%])

    Measured: Baseline to 7 months post-implant

  4. New York Heart Association (NYHA) Class

    Measured: Baseline to 7 months post-implant

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

    Measured: Baseline to 7 months post-implant

  6. Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day])

    Measured: Baseline to 7 months post-implant

  7. Heart rate variability [ms]

    Measured: Baseline to 7 months post implant

  8. Amount of hospitalizations because of heart failure (amount and duration [days])

    Measured: Baseline to 7 months post-implant

  9. Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s])

    Measured: Baseline to 7 months post-implant

  10. Mortality

    Measured: Baseline to 7 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionAug 2008
  4. Study completionAug 2008

Why it stopped: Due to existing evidence eligible patients receive CRT treatment in first place

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157846
Sponsor's protocol ID
CEN_G_CA_1
Status last verified
Feb 2017
First submitted
9 Sep 2005
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CRT-P or CRT-D Device in people with Heart Failure, Congestive, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to existing evidence eligible patients receive CRT treatment in first place). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary performance measured by spiroergometry (time frame: Baseline to 7 months post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00157846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.

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