TachycardiaNCT01548755
The Western Galilee Hospital in Nahariya Home Monitoring Registry
An observational study of Tachycardia, run by ron sela at 1 site in Israel.
Trial summary
The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tachycardia
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD or CRTD implanted patient
Who may be able to join
- 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.
Who cannot join
- No indication for ICD or CRTD implant.
- Life expectancy shorter than 12 months.
- Pregnancy.
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Western Galilee Hospital in Nahariya
Nahariya
Ron Sela, MD, 972 4 9107438, Ron.Sela@naharia.health.gov.il
Ron Sela, MD
About this study
Official title: Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.
The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.
Read the detailed 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.
- Conditions
- Tachycardia
- Keywords
- Home monitoring, cardiomessenger, ICD
- Medical subject headings
- Tachycardia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startApr 2012
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ron sela
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, ron sela, Western Galilee Hospital-Nahariya
- Investigators
- Ron Sela, MD, Principal investigator, The Western Galilee Hospital in Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548755
- Sponsor's protocol ID
- HMR_Naharia
- Status last verified
- Mar 2012
- First submitted
- 5 Mar 2012
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workload Assessment of a Home Monitoring Based Follow up for Biotronik ICD and CRTD Patients.
- ClinicalTrials.gov ID
- NCT01548755
- Acronym / sponsor ID
- HMR_Naharia
- Conditions
- Tachycardia
- Keywords
- Home monitoring, cardiomessenger, ICD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ron selaOther government
- Study start
- Apr 2012
- Study completion
- Jan 2015 (estimated)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study workload assessment of home monitoring based follow up for ICD or CRTD implanted patient.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD or CRTD implanted patient
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- No indication for ICD or CRTD implant.
- Life expectancy shorter than 12 months.
- Pregnancy.
- Participation in other clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
Related trials for Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
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Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Sela, MD principal investigator
The Western Galilee Hospital in Nahariya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia, run by ron sela at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ron Sela, MD (972 4 9107438, Ron.Sela@naharia.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.