N/A
N=200
CoreValve Advance-II Study: Prospective International Post-market Study
Aortic Valve Stenosis · Valvular Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT01624870 ↗Enrolled (actual)
200
Serious AEs
58.3%
Results posted
Jul 2018
Primary outcome: Primary: New-onset Class I or II Indication for Permanent Pacemaker Implantation — 13.3; 21.4 Percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New-onset Class I or II Indication for Permanent Pacemaker Implantation |
13.3; 21.4 | — |
| SECONDARY Combined Safety Endpoint |
6.7 | — |
Summary
The CoreValve ADVANCE-II Study is a best practices investigation of patients implanted with the Medtronic CoreValve bioprosthesis.
Eligibility Criteria
Inclusion Criteria
- Fulfilling the criteria of labeling indications of the CoreValve System;
- Patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race;
- Provided Signed Informed Consent or Data Release Form.
Exclusion Criteria
- Patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator);
- Patients with a pre-existing class I or class II indication for new pacemaker implantation according to the 2007 ESC guidelines;
- Persistent or permanent atrial fibrillation (except paroxysmal AF);
- Participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study.
- High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01624870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.