Implantable Defibrillator UserGulfICDNCT02491853

The Gulf Implantable Cardioverter-Defibrillator Registry

An observational study of Implantable Defibrillator User, run by Gulf Heart Association at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Implantable Defibrillator User
What is being tested?: Implantable Cardioverter Defibrillator
Type of treatment: Medical device
How many people: 1,545 participants
Where: 1 siteUnited Arab Emirates
Study dates: Jan 2014to Jun 2016
How long will I take part?: 1 Year
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patient receiving de nove implantable cardioverter defibrillator for primary or secondary prevention of sudden cardiac death

Who may be able to join

New implantable cardioverter defibrillator
Written consent

Who cannot join

Pulse generator replacements or system revisions
Failure to obtain written consent

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

Sheikh Khalifa Medical City
Abu Dhabi

Other trials in United Arab Emirates

About this study

Official title: The Gulf Implantable Cardioverter-Defibrillator Registry (GulfICD)

This is a prospective observational multi-center multi-national study of the characteristics and outcomes of patients receiving implantable cardioverter-defibrillators (ICD) in the Arab Gulf region. A total of 1,500 patients will be enrolled. Data on baseline clinical characteristics, ICD programming parameters, inpatient outcomes, and clinical events such as mortality and ICD discharges over 1 year of follow-up will be collected.

Read the detailed description

INTRUDUCTION 1.1 Background and Rationale The implantable cardioverter-defibrillator (ICD) is an effective tool for the prevention of sudden cardiac death (SCD) in high-risk patients. The efficacy of the ICD in the secondary and primary prevention of SCD was demonstrated in several large randomized clinical trials. The evolution of clinical trials of ICD therapy for primary prevention of SCD and the adoption of current national practice guidelines has lead to a considerable increase in the use of ICDs worldwide. In the Arab Gulf region, utilization of ICD therapy in high-risk patients had increased in the past decade with the arrival of trained electrophysiologists in the Gulf states. While observational studies in the United States and Europe have evaluated ICD use in those regions, there are scarce data on how ICDs are being used in the Gulf. Few single center studies have reported early results, and to date there are no prospective multinational data on ICD use in the Gulf. The Gulf Implantable Cardioverter-Defibrillator Registry (GulfICD) will be the first prospective, multicentre, multinational, observational studies of patients receiving ICDs in the Arab Gulf states.
STUDY OBJECTIVES AND ENDPOINTS The primary objective of the study is to describe the characteristics and outcomes of patients receiving ICD in the Arab Gulf region. Once completed, the data collected from GulfICD will be available for further secondary analyses including a description of ICD implant indications and programming patterns in the Gulf. As this is an observational and descriptive study, no specific endpoint is considered primary. However, main outcomes to be measured include all-cause mortality and ICD discharges including appropriate discharges for ventricular tachyarrhythmias and inappropriate discharges for other causes. Other endpoints to be measured include adverse events in the immediate post-implant period.
STUDY DESIGN Gulf ICD is a prospective, multicentre, multinational observational study.
SUBJECT SELECTION 4.1 Inclusion Criteria All adult patients 18 years or older, receiving a new ICD implant and willing to sign a consent form will be eligible. 4.2 Exclusion Criteria Patients < 18 years and those not willing to sign a consent form. Subjects with existing ICDs undergoing pulse generator replacements or system revisions will not be included.
STUDY TREATMENTS All subjects will be treated per routine clinical practice. There will be no study-specific interventions/treatments.
STUDY PROCEDURES 6.1 Subject Withdrawal Subjects will have the right to withdraw from the study at anytime.
DATA VARIABLES 7.1 Data Variables Data variables to be collected are detailed in the attached case-report form(CRF) (Baseline CRF Appendix 1, Follow Up CRF Appendix 2). Data will be collected on paper CRF and then entered online. Variables to be collected at baseline will include the following domains: 1. Baseline Demographics, 2. Admission Characteristics, 3. Medical History and Risk Factors, 4. Diagnostic Procedures, 5. ICD Implant Procedure Characteristics, 6. ICD Programming, 7. Adverse Events, 8. Discharge Characteristics, 9. Discharge Medications, 10. Interim Events (during follow up). Variable definitions will be based on the American College of Cardiology/American Heart Association/Heart Rhythm Society 2006 Key Data Elements and Definitions for Electrophysiological Studies and Procedures and the American College of Cardiology National Cardiovascular Data Registry (NCDR) ICD Registry data dictionary (httpp://www.ncdr.com/Web NCDR/docs/public-data-collection-documents/icd_v2_datadictionary_codersdictionary_2-1.pdf?sfvrsn=2)
ADVERSE EVENT REPORTING 8.1 Adverse Events Reporting Since there will be no study-specific intervention/treatment, we do not expect study specific adverse events. However, adverse events that may be related to ICD implantation will be collected as per the attached CRF (Appendix 1).
DATA ANALYSIS 9.1 Sample Size Considerations Unlike randomized controlled trials where specific hypotheses are tested and primary comparative analyses are planned, observational studies and patient registries typically address descriptive objectives. Such objectives do not lend themselves to classic sample size/power calculations. Nonetheless, sample size considerations are important in the planning of registries. Typically, adequate sample size is required to ensure adequate precision around key outcomes and provide sufficient generalizability. With that in mind, we wanted to ensure adequate precision around two key outcomes: all-cause mortality and/or rate of appropriate ICD discharges at one year. To estimate an event rate of 10% at 1 year with a margin of error of 2% and 95% confidence intervals, a sample size of 829 patients is required. Since there is little guidance in the literature on such event rates among ICD recipients in the Gulf, and to compensate for losses to follow-up, we adjusted our sample size upwards to 1,000 patients. Sample size was later increased to 1,500 patients as additional funding became available. Such a sample size was considered logistically feasible given our experience with ICD implant rates in the Gulf. 9.2 Statistical Methods Standard descriptive statistics will be used to analyse the data. Continuous variables will be summarized using mean and standard deviation or median and 25th and 75th percentile when significant deviation from a normal distribution is observed. Categorical variables will be summarized using counts and percentages. Basic univariate comparisons will be performed using Student's t-test or the Wilcoxon rank sum test as appropriate for continuous variables, and the Chi square test for categorical variables. Associations between baseline variables and outcomes during follow-up will be assessed using logistic regression or when exact event dates are available Cox proportional hazard models.
QUALITY CONTROL AND QUALITY ASSURANCE There is no substitute for good conscious. The investigators and their personnel filling the CRFs are responsible for filling the forms honestly and accurately. All forms must be filled prospectively. Quality control checking mechanisms are implemented in the online CRF system to prevent entry of inconsistent variables.
DATA HANDLING AND RECORD KEEPING 11.1 Case Report Forms/Electronic Data Records A CRF is required and should be collected and completed for each patient. Online data entry of the CRF will be available. 11.2 Record Retention Investigators will retain the paper CRFs per local ethics regulations. Paper CRFs will be stored in a secure area with access only available to study investigators. The online CRF portal will be password protected.
ETHICS 12.1 Institutional Review Board/Ethics Committee Approval It is the responsibility of the investigator to get prospective approval of the study protocol, consent form, and any amendments from the local institutional review boards/ethic committee. 12.2 Ethical Conduct of the Study The study will be conducted in accordance with the protocol and applicable local regulatory requirements and laws. Study conduct will also conform to the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the General Assembly of the World Medical Association 12.3 Subject Information and Consent All investigators will ensure protections of subjects' personal data and subject names or identifiers will not be included on any reports or publications from the study. Each study subject will be informed about the study objectives and procedures and all questions will be answered. Subjects will have to sign a consent form to be enrolled in the study. The consent form must be in compliance with local regulatory requirements.
SPONSORSHIP GulfICD will be conducted under the auspices of the Gulf Heart Rhythm Society (GHRS) and the Gulf Heart Association (GHA). Partial funding for the development of the online CRF portal is provided by Medtronic, Inc.
STUDY STRUCTURE AND TIMELINE 14.1 Principal Investigators and Steering Committee Members The study co-principal investigators are: Dr Alawi Alsheikh-Ali, Dr Ahmad Hersi and Dr Adel Khalifa. Country-level Principal Investigators include: Dr Najib Alrawahi (Principal Investigator Gulf ICD-Oman), Dr Nidal Asaad (Principal Investigator Gulf ICD-Qatar), additional steering committee members at the time of this righting are: Dr Fayez Bokhari, Dr Ahmad Alfaqih and Dr Amin Daoulah (Kingdom of Saudi Arabia), Dr Fawzieh Alkandari (Kuwait), Dr Salim Al-Kaabi, Dr Omer Elhag, Dr Hani Sabbour and Dr Hosam Zaky (United Arab Emirates). Additional members will be added to the steering committee as more centers join the study. 14.2 Study Timeline Below is a tentative study timeline: Milestone Date Initial talks between GHRS and Medtronic October 2011 Formal solicitation of funding submitted to Medtronic April 2012 Funding approved by Medtronic June 2012 Contract Signed with software company to develop online CRF system November 2012 Draft protocol and CRF circulated to Steering Committee December 2012 Development of online CRF portal and finalizing protocol December 2012-July 2013 Final protocol and CRF approved by steering committee August 2013 Submit for Institutional Review Board(IRB) approvals August/September 2013 Pilot online CRF September/October 2013 Official study launch November 2013 Submit "Methodology manuscript" December 2013 Complete enrolment November 2014 Complete follow-up for all patients November 2015 Data cleaning throughout study duration Data lockout January 2016 Start data analysis January 2016 Draft "main results manuscript" March 2016 Submit "main results manuscript" May 2016 Drafting and submissions of other manuscripts May 2016 onwards
PUBLICATION OF STUDY RESULTS Results of GulfICD will be disseminated through peer-reviewed manuscripts, abstracts, and presentations. The co-principal investigators and steering committee will be solely responsible for analysis, writing, and decision to submit for publications/presentation of all abstracts and manuscripts. Members of the steering committee will be co-authors on all study manuscripts that utilize the shared registry data. Manuscripts/abstracts based on country- or site-level data will require co-authorship by all steering committee members from the relevant country or site. Outside co-authors will be included if they meet the authorship requirements per the guidelines established by the International Committee of Medical Journal Editors and outlined in "Uniform Requirements for Manuscripts Submitted to Biomedical Journals; http://www.icmje.org/ethical_1author.html".

Conditions: Implantable Defibrillator User
Being tested: Implantable Cardioverter Defibrillator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantable Cardioverter DefibrillatorDevice
Also called ICD
Implantable Cardioverter Defibrillator

What is being measured

The primary outcome is the main question the study is designed to answer.

All-Cause Mortality
Measured: One Year

Secondary outcomes (3)

Appropriate ICD Discharge
Measured: One Year
Inappropriate ICD Discharge
Measured: One Year
ICD Malfunction
Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jun 2016

First posted8 Jul 2015 (estimated)
Study startJan 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Implantable Defibrillator UserStudies 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: Cohort
Time perspective: Prospective
Enrolment: 1,545 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT02491853
Sponsor's protocol ID: GulfICD
Acronym: GulfICD
Status last verified: Aug 2016
First submitted: 1 Jul 2015
Last updated: 12 Aug 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Alsheikh-Ali AA, Hersi AS, Hamad AK, Al Fagih AR, Al-Samadi FM, Almusaad AM, Bokhari FA, Al-Kandari F, Al-Ghamdi BS, Al Rawahi N, Asaad N, Alkaabi S, Daoulah A, Zaky HA, Elhag O, Al Hebaishi YS, Sweidan R, Alanazi H, Chase D, Sabbour H, Al Meheiri M, Al Abri I, Amin M, Dagriri K, Ahmed AO, Shafquat A, Khan SH. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation. Heart Views. 2015 Oct-Dec;16(4):125-30. doi: 10.4103/1995-705X.172193.
PubMed 26900416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Implantable Defibrillator User
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Recruiting
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All Implantable Defibrillator User trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Gulf Implantable Cardioverter-Defibrillator Registry (GulfICD)
ClinicalTrials.gov ID: NCT02491853
Acronym / sponsor ID: GulfICD / GulfICD
Conditions: Implantable Defibrillator User
Study type: Observational
Recruitment status: Completed
Enrolment: 1,545 participants (actual)
Lead sponsor: Gulf Heart AssociationUniversity, hospital or other
Collaborators: Medtronic, Boston Scientific Corporation
Study start: Jan 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 8 Jul 2015 (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.

Detailed description

INTRUDUCTION 1.1 Background and Rationale The implantable cardioverter-defibrillator (ICD) is an effective tool for the prevention of sudden cardiac death (SCD) in high-risk patients. The efficacy of the ICD in the secondary and primary prevention of SCD was demonstrated in several large randomized clinical trials. The evolution of clinical trials of ICD therapy for primary prevention of SCD and the adoption of current national practice guidelines has lead to a considerable increase in the use of ICDs worldwide. In the Arab Gulf region, utilization of ICD therapy in high-risk patients had increased in the past decade with the arrival of trained electrophysiologists in the Gulf states. While observational studies in the United States and Europe have evaluated ICD use in those regions, there are scarce data on how ICDs are being used in the Gulf. Few single center studies have reported early results, and to date there are no prospective multinational data on ICD use in the Gulf. The Gulf Implantable Cardioverter-Defibrillator Registry (GulfICD) will be the first prospective, multicentre, multinational, observational studies of patients receiving ICDs in the Arab Gulf states.
STUDY OBJECTIVES AND ENDPOINTS The primary objective of the study is to describe the characteristics and outcomes of patients receiving ICD in the Arab Gulf region. Once completed, the data collected from GulfICD will be available for further secondary analyses including a description of ICD implant indications and programming patterns in the Gulf. As this is an observational and descriptive study, no specific endpoint is considered primary. However, main outcomes to be measured include all-cause mortality and ICD discharges including appropriate discharges for ventricular tachyarrhythmias and inappropriate discharges for other causes. Other endpoints to be measured include adverse events in the immediate post-implant period.
STUDY DESIGN Gulf ICD is a prospective, multicentre, multinational observational study.
SUBJECT SELECTION 4.1 Inclusion Criteria All adult patients 18 years or older, receiving a new ICD implant and willing to sign a consent form will be eligible. 4.2 Exclusion Criteria Patients < 18 years and those not willing to sign a consent form. Subjects with existing ICDs undergoing pulse generator replacements or system revisions will not be included.
STUDY TREATMENTS All subjects will be treated per routine clinical practice. There will be no study-specific interventions/treatments.
STUDY PROCEDURES 6.1 Subject Withdrawal Subjects will have the right to withdraw from the study at anytime.
DATA VARIABLES 7.1 Data Variables Data variables to be collected are detailed in the attached case-report form(CRF) (Baseline CRF Appendix 1, Follow Up CRF Appendix 2). Data will be collected on paper CRF and then entered online. Variables to be collected at baseline will include the following domains: 1. Baseline Demographics, 2. Admission Characteristics, 3. Medical History and Risk Factors, 4. Diagnostic Procedures, 5. ICD Implant Procedure Characteristics, 6. ICD Programming, 7. Adverse Events, 8. Discharge Characteristics, 9. Discharge Medications, 10. Interim Events (during follow up). Variable definitions will be based on the American College of Cardiology/American Heart Association/Heart Rhythm Society 2006 Key Data Elements and Definitions for Electrophysiological Studies and Procedures and the American College of Cardiology National Cardiovascular Data Registry (NCDR) ICD Registry data dictionary (httpp://www.ncdr.com/Web NCDR/docs/public-data-collection-documents/icd_v2_datadictionary_codersdictionary_2-1.pdf?sfvrsn=2)
ADVERSE EVENT REPORTING 8.1 Adverse Events Reporting Since there will be no study-specific intervention/treatment, we do not expect study specific adverse events. However, adverse events that may be related to ICD implantation will be collected as per the attached CRF (Appendix 1).
DATA ANALYSIS 9.1 Sample Size Considerations Unlike randomized controlled trials where specific hypotheses are tested and primary comparative analyses are planned, observational studies and patient registries typically address descriptive objectives. Such objectives do not lend themselves to classic sample size/power calculations. Nonetheless, sample size considerations are important in the planning of registries. Typically, adequate sample size is required to ensure adequate precision around key outcomes and provide sufficient generalizability. With that in mind, we wanted to ensure adequate precision around two key outcomes: all-cause mortality and/or rate of appropriate ICD discharges at one year. To estimate an event rate of 10% at 1 year with a margin of error of 2% and 95% confidence intervals, a sample size of 829 patients is required. Since there is little guidance in the literature on such event rates among ICD recipients in the Gulf, and to compensate for losses to follow-up, we adjusted our sample size upwards to 1,000 patients. Sample size was later increased to 1,500 patients as additional funding became available. Such a sample size was considered logistically feasible given our experience with ICD implant rates in the Gulf. 9.2 Statistical Methods Standard descriptive statistics will be used to analyse the data. Continuous variables will be summarized using mean and standard deviation or median and 25th and 75th percentile when significant deviation from a normal distribution is observed. Categorical variables will be summarized using counts and percentages. Basic univariate comparisons will be performed using Student's t-test or the Wilcoxon rank sum test as appropriate for continuous variables, and the Chi square test for categorical variables. Associations between baseline variables and outcomes during follow-up will be assessed using logistic regression or when exact event dates are available Cox proportional hazard models.
QUALITY CONTROL AND QUALITY ASSURANCE There is no substitute for good conscious. The investigators and their personnel filling the CRFs are responsible for filling the forms honestly and accurately. All forms must be filled prospectively. Quality control checking mechanisms are implemented in the online CRF system to prevent entry of inconsistent variables.
DATA HANDLING AND RECORD KEEPING 11.1 Case Report Forms/Electronic Data Records A CRF is required and should be collected and completed for each patient. Online data entry of the CRF will be available. 11.2 Record Retention Investigators will retain the paper CRFs per local ethics regulations. Paper CRFs will be stored in a secure area with access only available to study investigators. The online CRF portal will be password protected.
ETHICS 12.1 Institutional Review Board/Ethics Committee Approval It is the responsibility of the investigator to get prospective approval of the study protocol, consent form, and any amendments from the local institutional review boards/ethic committee. 12.2 Ethical Conduct of the Study The study will be conducted in accordance with the protocol and applicable local regulatory requirements and laws. Study conduct will also conform to the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects adopted by the General Assembly of the World Medical Association 12.3 Subject Information and Consent All investigators will ensure protections of subjects' personal data and subject names or identifiers will not be included on any reports or publications from the study. Each study subject will be informed about the study objectives and procedures and all questions will be answered. Subjects will have to sign a consent form to be enrolled in the study. The consent form must be in compliance with local regulatory requirements.
SPONSORSHIP GulfICD will be conducted under the auspices of the Gulf Heart Rhythm Society (GHRS) and the Gulf Heart Association (GHA). Partial funding for the development of the online CRF portal is provided by Medtronic, Inc.
STUDY STRUCTURE AND TIMELINE 14.1 Principal Investigators and Steering Committee Members The study co-principal investigators are: Dr Alawi Alsheikh-Ali, Dr Ahmad Hersi and Dr Adel Khalifa. Country-level Principal Investigators include: Dr Najib Alrawahi (Principal Investigator Gulf ICD-Oman), Dr Nidal Asaad (Principal Investigator Gulf ICD-Qatar), additional steering committee members at the time of this righting are: Dr Fayez Bokhari, Dr Ahmad Alfaqih and Dr Amin Daoulah (Kingdom of Saudi Arabia), Dr Fawzieh Alkandari (Kuwait), Dr Salim Al-Kaabi, Dr Omer Elhag, Dr Hani Sabbour and Dr Hosam Zaky (United Arab Emirates). Additional members will be added to the steering committee as more centers join the study. 14.2 Study Timeline Below is a tentative study timeline: Milestone Date Initial talks between GHRS and Medtronic October 2011 Formal solicitation of funding submitted to Medtronic April 2012 Funding approved by Medtronic June 2012 Contract Signed with software company to develop online CRF system November 2012 Draft protocol and CRF circulated to Steering Committee December 2012 Development of online CRF portal and finalizing protocol December 2012-July 2013 Final protocol and CRF approved by steering committee August 2013 Submit for Institutional Review Board(IRB) approvals August/September 2013 Pilot online CRF September/October 2013 Official study launch November 2013 Submit "Methodology manuscript" December 2013 Complete enrolment November 2014 Complete follow-up for all patients November 2015 Data cleaning throughout study duration Data lockout January 2016 Start data analysis January 2016 Draft "main results manuscript" March 2016 Submit "main results manuscript" May 2016 Drafting and submissions of other manuscripts May 2016 onwards
PUBLICATION OF STUDY RESULTS Results of GulfICD will be disseminated through peer-reviewed manuscripts, abstracts, and presentations. The co-principal investigators and steering committee will be solely responsible for analysis, writing, and decision to submit for publications/presentation of all abstracts and manuscripts. Members of the steering committee will be co-authors on all study manuscripts that utilize the shared registry data. Manuscripts/abstracts based on country- or site-level data will require co-authorship by all steering committee members from the relevant country or site. Outside co-authors will be included if they meet the authorship requirements per the guidelines established by the International Committee of Medical Journal Editors and outlined in "Uniform Requirements for Manuscripts Submitted to Biomedical Journals; http://www.icmje.org/ethical_1author.html".

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient receiving de nove implantable cardioverter defibrillator for primary or secondary prevention of sudden cardiac death

Key inclusion criteria (2 listed)

New implantable cardioverter defibrillator
Written consent

Key exclusion criteria (2 listed)

Pulse generator replacements or system revisions
Failure to obtain written consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Implantable Cardioverter DefibrillatorAlso: ICDImplantable Cardioverter Defibrillator	Device	–

Primary outcome

All-Cause Mortality
Time frame: One Year

3 secondary outcomes

Appropriate ICD Discharge
Time frame: One Year
Inappropriate ICD Discharge
Time frame: One Year
ICD Malfunction
Time frame: One Year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
Background: PubMed 26900416Alsheikh-Ali AA, Hersi AS, Hamad AK, Al Fagih AR, Al-Samadi FM, Almusaad AM, Bokhari FA, Al-Kandari F, Al-Ghamdi BS, Al Rawahi N, Asaad N, Alkaabi S, Daoulah A, Zaky HA, Elhag O, Al Hebaishi YS, Sweidan R, Alanazi H, Chase D, Sabbour H, Al Meheiri M, Al Abri I, Amin M, Dagriri K, Ahmed AO, Shafquat A, Khan SH. The Gulf Implantable Cardioverter-defibrillator Registry: Rationale, Methodology, and Implementation. Heart Views. 2015 Oct-Dec;16(4):125-30. doi: 10.4103/1995-705X.172193.
Individual participant dataSharing planned: No

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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.

Alawi A. Alsheikh-Ali, MD principal investigator

Sheikh Khalifa Medical City, Abu Dhabi, UAE

Ahmad S. Hersi, MD principal investigator

King Saud University, Riyadh, KSA

Adel Khalifa, MD principal investigator

Bahrain Defence Force Hospital, Manama, Bahrain

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 Implantable Defibrillator User, run by Gulf Heart Association at 1 site in United Arab Emirates.

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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Aug 2016. 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 United Arab Emirates. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Mortality (time frame: One Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02491853, which also lists 1 linked publication.

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 12 Aug 2016.