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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00157846
• Other study ID #: CEN_G_CA_1
• Status: Terminated
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 14, 2017
• Start date: October 2003
• Est. completion date: August 2008

Study information

• Verified date: February 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Heart Failure
• Heart Failure, Congestive

Intervention

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

Locations

Country	Name	City	State
Germany	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	Luedenscheid
Germany	Krankenhaus Reinbek St. Adolf Stift	Reinbek b. Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary performance measured by spiroergometry	Maximal oxygen uptake (Vo2 max [ml/kg/min])	Baseline to 7 months post-implant
Secondary	Left ventricular end diastolic diameter (LVEDD [mm])		Baseline to 7 months post-implant
Secondary	N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml]		Baseline to 7 months post-implant
Secondary	Left ventricular ejection fraction (LVEF [%])		Baseline to 7 months post-implant
Secondary	New York Heart Association (NYHA) Class		Baseline to 7 months post-implant
Secondary	Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day])		Baseline to 7 months post-implant
Secondary	Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day])		Baseline to 7 months post-implant
Secondary	Heart rate variability [ms]		Baseline to 7 months post implant
Secondary	Amount of hospitalizations because of heart failure (amount and duration [days])		Baseline to 7 months post-implant
Secondary	Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s])		Baseline to 7 months post-implant
Secondary	Mortality		Baseline to 7 months post-implant