N/A
N=50
Sensor Optimization of Cardiac Resynchronization Therapy Response
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01832493 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Aug 2016
Primary outcome: Primary: AV Interval Determination Using Impedance — 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiac Resynchronization Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AV Interval Determination Using Impedance |
14 | — |
| PRIMARY AV Interval Determination Using Heart Sounds |
11 | — |
| PRIMARY Optimal Electrode Configuration Determination Using Impedance |
8 | — |
| PRIMARY Optimal Electrode Configuration Determination Using Heart Sounds |
12 | — |
Summary
The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.
Eligibility Criteria
Inclusion Criteria
- Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
- Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
- Subject (or subject's legally authorized representative) must be willing to give informed consent
- Subjects must be at least 18 years of age
Exclusion Criteria
- Subject has congenital heart disease
- Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
- Subject has unstable coronary artery disease
- Subject cannot undergo transvenous catheterization
- Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
- Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
- Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
- Subject is pregnant
- Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
Data sourced from ClinicalTrials.gov (NCT01832493). 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.