Clinical Trials Logo
  1. Home
  2. Tachycardia
  3. NCT01548755
  4. Details
NCT01548755 Clinical Trial

The Western Galilee Hospital in Nahariya Home Monitoring Registry

Tachycardia Clinical Trial

Official title:
Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01548755
Other study ID # HMR_Naharia
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 5, 2012
Last updated March 12, 2012
Start date April 2012
Est. completion date January 2015

Study information
Verified date March 2012
Source Western Galilee Hospital-Nahariya
Contact Ron Sela, MD
Phone 972 4 9107438
Email Ron.Sela@naharia.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.

Description:

EP unit device clinic is a very busy clinic. Every 6 month the patients arrive for device follow up where the device parameters, patient condition and arrhythmic events are being reviewed, and reprogramming of the device (if needed) is done. Average net time of patient's stay in the clinic is between 30-45 minutes.

Patients implanted with the Lumax device family allows for a better automated follow up procedure via remote management (Home Monitoring).

The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date January 2015
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Approved indication for ICD or CRTD.

- Implanted with or replaced with a Biotronik Lumax device.

- Patient is willing and able to sign consent form.

- Willing and able to attend clinic visits and follow up schedule.

- Transmission of more than 80% at 3-month FU.

- Patient older than 18 years.

Exclusion Criteria:

- No indication for ICD or CRTD implant.

- Life expectancy shorter than 12 months.

- Pregnancy.

- Participation in other clinical studies

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel The Western Galilee Hospital in Nahariya Nahariya

Sponsors (1)
Lead Sponsor Collaborator
ron sela

Country where clinical trial is conducted

Israel, 

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT05049720 - ExtraVascular Implantable Cardiac Defibrillator Continued Access Study N/A
Completed NCT02941250 - Acute Defibrillation Performance of a Novel Can-less Shock Pathway N/A
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT04060680 - Extravascular ICD Pivotal Study N/A
Recruiting NCT06048731 - Enlighten Study: The EV-ICD Post Approval Registry
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Completed NCT01772576 - Safety and Performance Study of the Reliance 4-Front Lead N/A
Completed NCT01410552 - Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination N/A
Completed NCT00542854 - iPod and Other MP3 Players on ICDs and Pacemakers in Children N/A
Completed NCT02877693 - A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging N/A
Recruiting NCT06038123 - China 3T MRI Study N/A
Completed NCT01754064 - St. Jude Medical Product Longevity and Performance (SCORE) Registry
Completed NCT00402246 - CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision N/A
Active, not recruiting NCT03940066 - Evaluation of Ambulatory Monitoring of Patients After High-risk Acute Coronary Syndrome Using Two Different Systems: Biomonitor-2 and Kardia Mobile N/A
Completed NCT03012568 - Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems
Completed NCT02772380 - Acute Study to Collect Electrical Signals From the Heart Using a Special Lead N/A
Completed NCT01377051 - Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea Phase 4
Completed NCT00820625 - Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation N/A