Heart Failure Clinical Trial
Official title:
Registry on Automatic Algorhitm on Atrial Capture: REAL ACap Registry
Verified date | March 2015 |
Source | Maria Vittoria Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Observational |
The main objective of this study is to verify the effectiveness of the new ACAP ® Confirm algorithm in the automatic management of atrial capture.
Status | Completed |
Enrollment | 318 |
Est. completion date | March 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients had undergone first implantation or device replacement with a Medical device (PM, ICD, CRT-P, CRT-D) endowed with ACAP Confirm ® algorithm features between May 2011 and March 2012 Exclusion Criteria: - Atrial fibrillation |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maria Vittoria Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main objective of this study is to verify the effectiveness of the new ACAP Confirm ® algorithm in management of atrial capture in both new implants and patients undergoing device replacements with different manufactures atrial leads. | 6 Months | No | |
Secondary | Relationship with pulse width | 6 Months | No | |
Secondary | Clinical equivalence of automatic and manual thresholds tests results. | 6 Months | No |
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