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
  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: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • True DFTs in fixed tilt and tuned waveforms obtained in joules (J) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Experimental: 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.
Active Comparator: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00873691     History of Changes
Other Study ID Numbers: CRD 442
Study First Received: March 30, 2009
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
Patients indicated for an ICD/ CRT-D

ClinicalTrials.gov processed this record on April 17, 2014