View Clinical Trial (Medical Research Study)
Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
| City: |
|
Columbia |
| State: |
|
South Carolina |
| Zip Code: |
|
29204 |
| Conditions: |
|
Tachycardia |
| Purpose: |
|
Reduce inappropriate ICD shocks, that cause painful experience and have a detrimental effect
on patient's quality of life, is still an important issue to be solved.
ISIS- ICD study has been designed to confirm that, with the PARAD+ algorithm, it is possible
to have an increase of patients free from inappropriate shocks in a general population
implanted for primary or secondary prevention with a dual or tri chamber device during one
year follow-up
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- Patient eligible for implantation (according to current accepted guidelines, or
scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF
(CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the
last 30 days
- Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or
patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned
within three months
- Signed and dated informed consent (according to the laws and regulations of the
country in which the research is performed)
Exclusion Criteria:
1. Any contraindication for ICD therapy
2. Atrial lead not implanted
3. Patient with permanent atrial tachyarrhythmia
4. Post heart transplant or patients who are waiting for a heart transplant
5. Patients implanted with a ventricular assist device (VAD)
6. Already included in another clinical study that could confound the results of this
study
7. Inability to understand the purpose of the study or refusal to cooperate
8. Unavailability for scheduled follow-up
9. Less than 18 years of age
10. Documented drug addiction or abuse that could interfere with study compliance
11. Pregnancy
12. Under guardianship
|
| NCT ID: |
|
NCT01410552 |
| Primary Contact: |
|
Principal Investigator
Ricardo RUIZ GRANELL, Dr
Cardiology Department Arrhythmia Unit Hospital Clinico Universitario Valencia SPAIN
Mara Rolando
Phone: 39 0161 487 448
Email: mara.rolando@sorin.com
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Columbia, South Carolina 29204
United States
Malanuk Robert, Doctor
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 20, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|