Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001530
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Long-Term Results of DDD Pacing in Obstructive Hypertrophic Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
1999-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
DDD pacing improves symptoms and relieves LV outflow tract LVOT obstruction in most patients with hypertrophic cardiomyopathy HCM Notably when pacing is temporarily discontinued the beneficial effects of pacing are evident in sinus rhythm The long term results of this novel therapy are however uncertain We propose 1 to record the hemodynamic changes following 4 years of pacing and 2 to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction Patients who have had 50 reduction in LVOT pressure gradients will be randomized to two pacing modalities DDD at 70 beats per minute and AAI pacing at 70 beats per minute DDD switched off and reevaluated after a six-month period
Detailed Description:
DDD pacing improves symptoms and relieves LV outflow tract LVOT obstruction in most patients with hypertrophic cardiomyopathy HCM Notably when pacing is temporarily discontinued the beneficial effects of pacing are evident in sinus rhythm The long term results of this novel therapy are however uncertain We propose 1 to record the hemodynamic changes following 4 years of pacing and 2 to determine whether DDD pacing continues to be necessary in patients who have had a substantial relief of their LVOT obstruction Patients who have had 50 reduction in LVOT pressure gradients will be randomized to two pacing modalities DDD at 70 beats per minute and AAI pacing at 70 beats per minute DDD switched off and reevaluated after a six-month period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-H-0059 | None | None | None |