Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants (Tilt & Tune)
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.
Full description
Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).
The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patient meets standard indication for an ICD/ CRT-D
- Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
- Pulse generator will be implanted on the right-side
- Patient is able to tolerate DFT testing.
- RV lead will be placed in the RV apex or inferior septum
Exclusion criteria
- Patient is pregnant.
- Patient is less than 18 years old.
- SVC coil was turned ON during DFT testing
Trial design
129 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal