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

Sudden Cardiac Death Clinical Trial

— PROMISE  

Official title:

Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in a Single Coil Active Can Configuration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874445
• Other study ID #: CRD 475
• Status: Completed
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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between the tuned and 50% tilt waveforms is amplified at high impedance levels with tuned waveforms being superior (unpublished).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

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.

Locations

Country	Name	City	State
United States	Michael Gold	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

References & Publications (4)

Gold M, Val-Mejias J, Leman RB, Tummala R, Goyal S, Kluger J, Kroll M, Oza A. Optimization of superior vena cava coil position and usage for transvenous defibrillation. Heart Rhythm. 2008 Mar;5(3):394-9. doi: 10.1016/j.hrthm.2007.12.001. Epub 2007 Dec 5. — View Citation

Gold MR, Val-Mejias J, Cuoco F, Siddiqui M. Comparison of fixed tilt and tuned defibrillation waveforms: the PROMISE study. J Cardiovasc Electrophysiol. 2013 Mar;24(3):323-7. doi: 10.1111/jce.12041. Epub 2012 Dec 4. — View Citation

Mouchawar G, Kroll M, Val-Mejias JE, Schwartzman D, McKenzie J, Fitzgerald D, Prater S, Katcher M, Fain E, Syed Z. ICD waveform optimization: a randomized, prospective, pair-sampled multicenter study. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1992-5. — View Citation

Natarajan S, Henthorn R, Burroughs J, Esberg D, Zweibel S, Ross T, Kroll M, Gianola D, Oza A. "Tuned" defibrillation waveforms outperform 50/50% tilt defibrillation waveforms: a randomized multi-center study. Pacing Clin Electrophysiol. 2007 Jan;30 Suppl 1:S139-42. Erratum in: Pacing Clin Electrophysiol. 2007 Nov;30(11):1424. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True DFTs in fixed tilt and tuned waveforms obtained in volts (V)		Implant
Secondary	True DFTs in fixed tilt and tuned waveforms obtained in joules (J)		Implant