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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873691
First Posted: April 1, 2009
Last Update Posted: June 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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.

Condition Intervention Phase
Healthy Device: ICD Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V) [ Time Frame: Baseline ]

Secondary Outcome Measures:
  • True DFTs in fixed tilt and tuned waveforms obtained in joules (J) [ Time Frame: Baseline ]

Enrollment: 129
Study Start Date: March 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
ICD shocks programmed to Tuned Waveform
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.
2
ICD shocks programmed to 50% Tilt waveform
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with approved ICD/CRT-D indications
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873691


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Niraj Varma, MD The Cleveland Clinic