TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
Study Details
Study Description
Brief Summary
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and define endpoints for a larger randomized study. The study will assess the HM-parameter trends correlation with daily weight and blood pressure changes. The patient compliance rate of the two different telemonitoring systems (HM & ETM) will also be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
This single-arm, multi-center feasibility study will explore the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up management of heart failure patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The BIOTRONIK Home Monitoring system will automatically and remotely collect device based information on a daily basis, and an external telemonitoring system will be used to determine the 'weight' and 'blood pressure' remotely at the patient's home on a daily basis. This study will evaluate retrospectively, if Home Monitoring parameters correlate with weight and blood pressure changes. The patient compliance rate of the two telemonitoring systems will also be assessed.
Target enrollment is up to 100 patients at 15 U.S. sites. Patients will be enrolled within a period of 12 to 15 months. Based on the follow-up period of 6 months per patient, the study duration is 18 to 21 months from the date of first patient enrollment. All patients will give written informed consent prior to enrollment and will be implanted with the legally marketed BIOTRONIK Kronos LV-T, or an appropriate BIOTRONIK CRT-D, as well as legally marketed pacing and defibrillation leads. In addition, all patients will be receiving a legally marketed external telemonitoring system to determine weight and blood pressure at home.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HM with weight and BP remote monitoring Device based Home Monitoring and weight and blood pressure remote monitoring |
Device: Kronos LV-T, Lumax HF-T
Implanted CRT-device sends out device diagnostics (e.g. heart rate, device and lead integrity, patient activity) via CardioMessenger on daily basis. In addition, daily weight and blood pressure readings are taken; remote data are analyzed by investigational sites via the internet on a weekly basis.
|
Outcome Measures
Primary Outcome Measures
- Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. [6 months]
Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to provide written informed consent
-
Implanted within the past 45 days or being considered for implant with a BIOTRONIK CRT-D
-
Age 18 years
-
Able to follow and comply with the study related procedures
-
Phone jack with landline connection at home to connect both the BIOTRONIK HM and the ETM system
-
Sufficient cognitive and reading skills to operate weight & BP system Ambulatory
-
Weight ≤ 400 lbs
Exclusion Criteria:
-
Participation in another cardiovascular clinical study
-
Life expectancy <6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maricopa Medical Center | Phoenix | Arizona | United States | 85008 |
| 2 | Scottsdale Cardiology | Scottsdale | Arizona | United States | 85251 |
| 3 | Christiana Care Health Services | Wilmington | Delaware | United States | 19718 |
| 4 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
| 5 | Georgia Arrhythmia Consultants | Macon | Georgia | United States | 31201 |
| 6 | Loyola University Medical Center | Chicago | Illinois | United States | 60135 |
| 7 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 8 | Thoracic & Cardiovascular Institute | Lansing | Michigan | United States | 48910 |
| 9 | St. Louis Heart and Vascular | St. Louis | Missouri | United States | 63136 |
| 10 | Cleveland Cardiovascular Research Foundation | Cleveland | Ohio | United States | 44126 |
| 11 | Pee Dee Cardiology | Florence | South Carolina | United States | 29506 |
| 12 | Spartanburg Regional | Spartanburg | South Carolina | United States | 29303 |
Sponsors and Collaborators
- Biotronik, Inc.
Investigators
- Principal Investigator: Joseph Akar, MD, Loyola University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20061653
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Home Monitoring With Weight and BP Remote Monitoring |
|---|---|
| Arm/Group Description | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring |
| Period Title: Overall Study | |
| STARTED | 66 |
| COMPLETED | 53 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Arm/Group Title | Home Monitoring With Weight and BP Remote Monitoring |
|---|---|
| Arm/Group Description | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring |
| Overall Participants | 66 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
37
56.1%
|
| >=65 years |
29
43.9%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65
(11)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
25.8%
|
| Male |
49
74.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
66
100%
|
Outcome Measures
| Title | Patient Compliance of Weight and Blood Pressure External Monitoring and Home Monitoring Transmissions. Percentage of Days Transmitted. |
|---|---|
| Description | Analyzed transmission periods for weight, blood pressure (BP) and Home Monitoring (HM) started with the respective first transmission. In patients where neither system transmitted data, the date of enrollment was taken as the start date of the analyzed period for all systems. If only one remote system transmitted data (e.g. HM or weight and BP data only), the first transmission date from the corresponding, successfully transmitting system was assumed as the start date of the analyzed period for the non-transmitting system. Analyzed transmission period ended with study exit or completion. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All Enrolled Participants |
| Arm/Group Title | Home Monitoring With Weight and BP Remote Monitoring |
|---|---|
| Arm/Group Description | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring |
| Measure Participants | 66 |
| Weight Telemonitoring |
71
|
| BP Telemonitoring |
71
|
| HM System |
83
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Home Monitoring With Weight and BP Remote Monitoring | |
| Arm/Group Description | Device based Home Monitoring with weight and blood pressure (BP) remote monitoring | |
All Cause Mortality |
||
| Home Monitoring With Weight and BP Remote Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Home Monitoring With Weight and BP Remote Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Home Monitoring With Weight and BP Remote Monitoring | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/66 (18.2%) | |
| Cardiac disorders | ||
| Heart Failure related Hospitalization | 6/66 (9.1%) | 9 |
| Complication | 3/66 (4.5%) | 4 |
| General disorders | ||
| Death | 4/66 (6.1%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigator agrees to submit copies of any proposed publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may delete any Confidential Information or other proprietary information. In addition, Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests.
Results Point of Contact
| Name/Title | Katerina de Metz (Director, Clinical Studies) |
|---|---|
| Organization | BIOTRONIK, Inc. |
| Phone | 800-547-0394 |
| katerina.demetz@biotronik.com |
- 20061653