N/A
N=31
Left Ventricular Synchronous Versus Sequential MultiSpot Pacing for Cardiac Resynchronization Therapy (CRT)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02914457 ↗Enrolled (actual)
31
Serious AEs
9.7%
Results posted
Aug 2020
Primary outcome: Primary: Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec) — 10.59; 12.20; 11.51; 15.64 % change LV dP/dt max
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electrophysiological Study (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Positive Left Ventricular dP/dt Max (mmHG/Sec) |
10.59; 12.20; 11.51; 15.64; 11.80 | — |
| SECONDARY Correlation Between Percentage Change LV dP/dt Max and Percentage Change Blood Pressure |
0.52; 0.37 | — |
| SECONDARY Correlation Between Percentage Change LV dP/dt Max and Percentage Change Non-Invasive Blood Pressure |
— | — |
| SECONDARY Correlation Between Percentage Change LV dP/dt Max and Q-LV Ratio |
0.20 | — |
| SECONDARY Correlation Between Percentage Change LV dP/dt Max and % Change QRS Width |
-0.28 | — |
Summary
The SYNSEQ study intends to assess the positive left ventricular dP/dt max achieved by MultiSpot LV pacing (either simultaneously or sequentially) in comparison to the response achieved by the current (standard) BiV pacing configuration in patients indicated/recommended for cardiac resynchronization therapy.
Eligibility Criteria
Inclusion Criteria
- Subject is indicated or recommended for CRT-P or CRT-D device according to current applicable ESC/AHA guidelines
- Subject is in sinus rhythm
- Subject receives optimal heart failure oral medical therapy
- Subject is willing to sign the informed consent form
- Subject is 18 years or older
Exclusion Criteria
- Subject has permanent atrial fibrillation/flutter or tachycardia
- Subject has pure right bundle branch block (= no additional left ventricular conduction delays)
- Subject has left bundle branch block and QRS-duration of > 150 ms and no sign of myocardial scar indicated by late gadolinium enhancement MRI
- Subject experienced recent myocardial infarction, within 40 days prior to enrollment
- Subject underwent valve surgery, within 90 days prior to enrollment
- Subject is post heart transplantation, or is actively listed on the transplantation list
- Subject is implanted with a left ventricular assist device
- Subject has severe renal disease (up to physicians discretion)
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
- Subject has severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated within study period)
- Subject has complex and uncorrected congenital heart disease
- Subject has a mechanical heart valve
- Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
- Subject is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager
Data sourced from ClinicalTrials.gov (NCT02914457). 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.