- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454050
Lumax 740 Master Study (Lumax 740)
November 27, 2012 updated by: Biotronik SE & Co. KG
PME/Master Study of the Lumax 740 ICD Family
The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family.
Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
189
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hannover, Germany, 30625
- Medical School Hannover
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with standard ICD indication who are referred to the hospital.
Description
Inclusion Criteria:
Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD.
- Legal capacity and ability to consent
- Signed patient informed consent
In addition for HF-T devices:
- Bipolar LV-lead with a min. distance of 15 mm between tip and ring
- True bipolar RV lead
Exclusion Criteria:
Standard contraindication for single, dual, or triple chamber ICD.
- Age < 18 years
- Pregnant or breast-feeding woman
- Cardiac surgery planned within the next 6 months
- Life expectancy of less than 6 months
- Participating in any other clinical study of an investigational cardiac drug or device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of the automatic Capture Control feature
Time Frame: PHD, 1-, 3- and 6-month follow-up
|
PHD, 1-, 3- and 6-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gunnar Klein, Prof. Dr., Herz im Zentrum Hannover, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
October 14, 2011
First Submitted That Met QC Criteria
October 17, 2011
First Posted (Estimate)
October 18, 2011
Study Record Updates
Last Update Posted (Estimate)
November 28, 2012
Last Update Submitted That Met QC Criteria
November 27, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 55
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Safety and Efficacy of the Lumax 740 ICD Family
-
Xijing HospitalUnknownThe Efficacy and Safety of Intranasal Dexmedetomidine
-
Population Health Research InstituteCharles University, Czech Republic; Centre hospitalier de l'Université de Montréal... and other collaboratorsCompletedthe Efficacy and Safety of Off-pump CABGCanada, China, Colombia, India, Chile, Argentina, Brazil, Czech Republic, France, Italy, Poland, Turkey, United Kingdom
-
Shanghai Zhongshan HospitalRecruiting
-
Lee's Pharmaceutical LimitedFidia Farmaceutici s.p.a.CompletedThe Primary Objective of This Study Was to Assess the Efficacy and Safety of Hyaluronic Acid Vaginal Gel in Treating Vaginal Dryness
-
Shanghai Zhongshan HospitalRecruiting
-
Fang WuXiangya Hospital of Central South University; Hunan Cancer Hospital; The Third...RecruitingThe Efficacy and Safety of SBRT in MPLCChina
-
Boston Children's HospitalTerminatedSafety and Efficacy of Sedation MedicationsUnited States
-
Taipei Medical University WanFang HospitalUnknownEfficacy and Safety of VATS Block
-
Bon Secours Pediatric Dental AssociatesUnknownSafety and Efficacy of Intranasal DexmedetomidineUnited States
-
Ankara City Hospital BilkentUnknownEfficacy and Safety of Novel Bidirectional CannulaTurkey