Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376116
Status:
COMPLETED
Last Update Posted:
2008-11-17
First Post:
2006-09-13
Brief Title:
Home Monitoring in Cardiac Resynchronisation Therapy
Sponsor:
Biotronik SE Co KG
Organization:
Biotronik SE Co KG
Study Overview
Official Title:
Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HomeCARE
Brief Summary:
In spite of success in the management of heart failure repetitive rehospitalisation and high mortality rate remain a serious problem Recent studies especially the COMPANION trial have demonstrated that cardiac resynchronisation therapy CRT reduces mortality and rehospitalisation in heart failure patients There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity Recently a Home Monitoring HM function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients physicians Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers
Detailed Description:
Clinical investigations identified potential predictors for mortality and rehospitalisation events in heart failure patients A selection of these predictors primarily composes the Heart Failure Monitor HFM which is implemented in Biotronik implantable cardioverter defibrillators ICDs capable of delivering cardiac resynchronisation therapy CRT as well as in CRT-pacemakers HFM and other parameters are transmitted to the attending physician via Home Monitoring HM function integrated in the implanted devices In the future a HFM with high predictive power may play an important role as part of a strategy of delivering effective health care for heart failure patients with an indication for CRT
Our included patients implanted with CRT devices STRATOS LV-T CRT-pacemaker KRONOS LV-T or Lumax HF-T CRT-ICD Pre-discharge protocol comprised standard device follow-up activation of the HM-function and assessment of complications and cardiovascular events At follow-up controls 1 3 6 9 and 12 months after implantation standard device follow-up was performed and complications and cardiovascular events were assessed
At enrollment 6 and 12 months postoperative and in case of a rehospitalisation the following parameters are documented
Echocardiographic parameters
Quality of Life Minnesota
ECG-parameters NYHA-classification
Blood pressure body weight
BNP NT-pro BNP optional
6 minute walk test optional
At 1 3 and 9 months postoperative
ECG-parameters NYHA-classification
Blood pressure body weight
BNP NT-pro BNP optional
6 minute walk test optional
Further documentation
Change of drug treatment
Any cardiovascular event and therapeutic intervention
Heart failure related symptoms by means of patient diary
Our included patients implanted with CRT devices STRATOS LV-T CRT-pacemaker KRONOS LV-T or Lumax HF-T CRT-ICD Pre-discharge protocol comprised standard device follow-up activation of the HM-function and assessment of complications and cardiovascular events At follow-up controls 1 3 6 9 and 12 months after implantation standard device follow-up was performed and complications and cardiovascular events were assessed
At enrollment 6 and 12 months postoperative and in case of a rehospitalisation the following parameters are documented
Echocardiographic parameters
Quality of Life Minnesota
ECG-parameters NYHA-classification
Blood pressure body weight
BNP NT-pro BNP optional
6 minute walk test optional
At 1 3 and 9 months postoperative
ECG-parameters NYHA-classification
Blood pressure body weight
BNP NT-pro BNP optional
6 minute walk test optional
Further documentation
Change of drug treatment
Any cardiovascular event and therapeutic intervention
Heart failure related symptoms by means of patient diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None