Clinical trial NCT00873691: Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
Official title: Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Patients indicated for an ICD/ CRT-D
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with approved ICD/CRT-D indications

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)
timeFrame: Baseline
Secondary outcomes:
measure: True DFTs in fixed tilt and tuned waveforms obtained in joules (J)
timeFrame: Baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Niraj Varma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varma N, Efimov I. Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil. Pacing Clin Electrophysiol. 2008 Aug;31(8):1025-35. doi: 10.1111/j.1540-8159.2008.01130.x.
citation: Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. doi: 10.1111/j.1540-8159.2007.00624.x.
citation: Varma N, Schaerf R, Kalbfleisch S, Pimentel R, Kroll MW, Oza A. Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial). Europace. 2017 Nov 1;19(11):1810-1817. doi: 10.1093/europace/euw306.