N/A
N=121
Post-market Study of Multi-Vector Left Ventricular Lead Performance in Chinese Patients With Chronic Heart Failure
Chronic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02367716 ↗Enrolled (actual)
121
Serious AEs
9.2%
Results posted
Nov 2020
Primary outcome: Primary: The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) — 2 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CRT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) |
2 | — |
| SECONDARY The Number of Participants With Effective LV Pacing |
48 | — |
| SECONDARY The Number of Participants in Each NYHA Functional Class |
12; 61; 26; 3; 3 | — |
| SECONDARY The Intrinsic QRS Duration of Participants |
141.9 | — |
Summary
The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).
Eligibility Criteria
Inclusion Criteria
- Meets the current European Society of Cardiology (ESC) or American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Rhythm Society (HRS) Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber Implantable Cardioverter-Defibrillators (ICDs))
- Are ≥ 18 years of age at the time of enrolment.
- Are able to provide written Informed Consent prior to any study related procedure.
Exclusion Criteria
- Patient who is unable to comply with the follow-up schedule.
- Patient who has any medical conditions that in the opinion of the investigator will not be appropriate to participate in the study .
- Patient has a life expectancy of less than 1 year due to any condition.
- Patients, who has a CRT device implanted
Data sourced from ClinicalTrials.gov (NCT02367716). 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.