Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants (Tilt & Tune)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00873691
First received: March 30, 2009
Last updated: December 11, 2012
Last verified: December 2012

March 30, 2009
December 11, 2012
March 2009
November 2011   (final data collection date for primary outcome measure)
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00873691 on ClinicalTrials.gov Archive Site
True DFTs in fixed tilt and tuned waveforms obtained in joules (J) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
True DFTs in fixed tilt and tuned waveforms obtained in joules (J) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants
Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Healthy
Device: ICD
Intervention isn an ICD. Patients in experimental group will have their ICDs programmed to Tuned waveform and those in the control group will have their ICDs programmed to Fixed Tilt waveform.
  • Experimental: 1
    ICD shocks programmed to Tuned Waveform
    Intervention: Device: ICD
  • Active Comparator: 2
    ICD shocks programmed to 50% Tilt waveform
    Intervention: Device: ICD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00873691
CRD 442
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Niraj Varma, MD The Cleveland Clinic
St. Jude Medical
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP