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Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration (PROMISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00874445
First received: March 31, 2009
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  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 a single coil active can configuration.


Condition Intervention Phase
Sudden Cardiac Death
 Device: ICD/ CRT-D
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • True DFTs in fixed tilt and tuned waveforms obtained in volts (V) [ Time Frame: Implant ] [ Designated as safety issue: No ]

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

Enrollment: 77
Study Start Date: March 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICD shocks programmed to Tuned Waveform
ICD shocks programmed to Tuned Waveform
 Device: ICD/ CRT-D
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: ICD shocks programmed to Fixed Tilt Waveform
ICD shocks programmed to Fixed Tilt Waveform
 Device: ICD/ CRT-D
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:

There has been one prospective study that found some benefit of using tuned waveforms over 50/50% tilt waveforms.11 Other studies have failed to show much change in defibrillation efficacy with different duration biphasic waveforms. A vast majority of patients in these studies were tested with dual coil leads. Although dual coil leads can lower defibrillation thresholds, it is known that dual coil leads can make the lead extraction difficult, lead to venous obstruction and are more prone to failure. Results from a recent study showed that that a single coil configuration is adequate in a vast majority of patients when DFT testing was performed with tuned waveforms. This makes the use of single-coil leads during ICD/ CRT-D implants an attractive option.

Theoretical analysis has shown that difference between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished). Accordingly, this study has been designed to prospectively compare the DFT estimates with tuned and 50% tilt waveforms in left-sided, active pectoral defibrillation lead systems when the SVC coil has been turned OFF or is not part of the shocking circuit.

  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 and will be implanted with an FDA approved SJM ICD/ CRT-D and compatible defibrillation lead system in the left pectoral region.
  • Patient is able to tolerate DFT testing.

Exclusion Criteria:

  • Patient has the pulse generator on the right side.
  • 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: NCT00874445

Locations
United States, South Carolina
Michael Gold
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Michael Gold, MD, PhD Medical University of South Carolina
  More Information

Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00874445     History of Changes
Other Study ID Numbers: CRD 475
Study First Received: March 31, 2009
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
 Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013