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

• Sponsor: Medtronic Bakken Research Center (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00157846
• Collaborator: Medtronic (Industry)
• Enrollment: 36
• Locations: 10
• Arms: 2
• Duration (Months): 58
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Device: CRT-P or CRT-D Device	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure to Investigate the Effect of Preventive Stimulation
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BiV Pacing Biventricular pacing for 3 months, subsequently right ventricular pacing for 3 months	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)
Active Comparator: RV Stimulation Right ventricular pacing for 3 months, subsequently biventricular pacing for 3 months	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)

Outcome Measures

Primary Outcome Measures

1. Cardiopulmonary performance measured by spiroergometry [Baseline to 7 months post-implant]

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

Secondary Outcome Measures

1. Left ventricular end diastolic diameter (LVEDD [mm]) [Baseline to 7 months post-implant]

2. N-terminal prohormone brain natriuretic peptide (NT-proBNP) [pg/ml] [Baseline to 7 months post-implant]

3. Left ventricular ejection fraction (LVEF [%]) [Baseline to 7 months post-implant]

4. New York Heart Association (NYHA) Class [Baseline to 7 months post-implant]

5. Occurrence of rhythm disturbances: atrial arrhythmias (amount and duration [h/day]) [Baseline to 7 months post-implant]

6. Occurrence of rhythm disturbances: ventricular arrhythmias (amount and duration [h/day]) [Baseline to 7 months post-implant]

7. Heart rate variability [ms] [Baseline to 7 months post implant]

8. Amount of hospitalizations because of heart failure (amount and duration [days]) [Baseline to 7 months post-implant]

9. Cardiopulmonary performance measured by spiroergometry: Oxygen uptake at the anaerobic threshold (VO2 AT [s]) [Baseline to 7 months post-implant]

10. Mortality [Baseline to 7 months post-implant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Augsburg I. Medizinische Klinik	Augsburg		Germany	86156
2	Charite Campus Virchow-Klinikum	Berlin		Germany	13353
3	Unfallkrankenhaus Benjamin Franklin	Berlin		Germany
4	Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg	Bernau		Germany
5	Berufsgenossenschaftliche Kliniken Bergmannsheil	Bochum		Germany	44789
6	Städtisches Kreiskrankenhaus	Friedrichshafen		Germany
7	Georg-August-Universität Göttingen	Göttingen		Germany
8	St.-Vincentius Klinken	Karlsruhe		Germany
9	Märkische Kliniken GmbH Klinikum Luedenscheid	Luedenscheid		Germany	58515
10	Krankenhaus Reinbek St. Adolf Stift	Reinbek b. Hamburg		Germany	21465

Sponsors and Collaborators

• Medtronic Bakken Research Center
• Medtronic

Investigators

• Principal Investigator: Thomas Lawo, MD, Berufsgenossenschaftliche Kliniken Bergmannsheil Bochum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Bakken Research Center
• ClinicalTrials.gov Identifier: NCT00157846
• Other Study ID Numbers: CEN_G_CA_1
• First Posted: Sep 12, 2005
• Last Update Posted: Feb 15, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Medtronic Bakken Research Center: Heart Failure; LVEF < 35%; Bradycardia
• Additional relevant MeSH terms: Heart Failure; Bradycardia

Study Results

No Results Posted as of Feb 15, 2017