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

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ClinicalTrials.gov Identifier: NCT00874445
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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 a single coil active can configuration.

Condition or disease Intervention/treatment
Sudden Cardiac Death Device: ICD/ CRT-D

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between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished).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.


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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration
Study Start Date : March 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Group/Cohort Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. True DFTs in fixed tilt and tuned waveforms obtained in volts (V) [ Time Frame: Implant ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with ICD/CRT-D indications
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

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): NCT00874445


Locations
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United States, South Carolina
Michael Gold
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Michael Gold, MD, PhD Medical University of South Carolina

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00874445     History of Changes
Other Study ID Numbers: CRD 475
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden