|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02547207 |
|
Date of registration:
|
07/05/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
MultiPoint Pacing Mapping Study
|
|
Scientific title:
|
MultiPoint Pacing Mapping Study |
|
Date of first enrolment:
|
December 2015 |
|
Target sample size:
|
7 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT02547207 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
|
Germany
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
Christophe Leclercq, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital Rennes, Rennes, France |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Be scheduled to undergo or have received within the past 30 days an implant of a SJM
(St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European
Society of Cardiology) / EHRA (European Heart Rhythm Association) Guidelines
- Have the ability to provide informed consent for study participation and be willing
and able to comply with the Clinical Investigation Plan (CIP) described evaluations
and follow-up schedule
- Be in sinus rhythm
Exclusion Criteria:
- Complete AV (atrioventricular) block
- Permanent atrial fibrillation
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac surgery or coronary revascularization procedure within 3 months
prior to enrollment or be scheduled for such procedures in the following 7 months
- Have had a recent CVA (cerebrovascular accident) or TIA (transient ischemic attack)
within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Be less than 18 years of age
- Be pregnant or plan to become pregnant over the next 7 months
- Have significant peripheral vascular disease
- Have LV thrombus
- Significant aortic valve disease or replacement
- Mitral valvular disease
- Contraindicated for Gadolinium contrast agent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Heart Failure
|
|
Primary Outcome(s)
|
|
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings
[Time Frame: up to 30 days post-implant]
|
|
Secondary ID(s)
|
|
CR-13-004-EU-HF
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|