The Gulf Implantable Cardioverter-Defibrillator Registry
GulfICD
1 other identifier
observational
1,545
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 12, 2016
August 1, 2016
2.4 years
July 1, 2015
August 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
All-Cause Mortality
One Year
Secondary Outcomes (3)
Appropriate ICD Discharge
One Year
Inappropriate ICD Discharge
One Year
ICD Malfunction
One Year
Interventions
Implantable Cardioverter Defibrillator
Eligibility Criteria
Patient receiving de nove implantable cardioverter defibrillator for primary or secondary prevention of sudden cardiac death
You may qualify if:
- New implantable cardioverter defibrillator
- Written consent
You may not qualify if:
- Pulse generator replacements or system revisions
- Failure to obtain written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gulf Heart Associationlead
- Medtroniccollaborator
- Boston Scientific Corporationcollaborator
Study Sites (1)
Sheikh Khalifa Medical City
Abu Dhabi, United Arab Emirates
Related Publications (1)
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.
PMID: 26900416BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alawi A. Alsheikh-Ali, MD
Sheikh Khalifa Medical City, Abu Dhabi, UAE
- PRINCIPAL INVESTIGATOR
Ahmad S. Hersi, MD
King Saud University, Riyadh, KSA
- PRINCIPAL INVESTIGATOR
Adel Khalifa, MD
Bahrain Defence Force Hospital, Manama, Bahrain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 8, 2015
Study Start
January 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 12, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share