Comparison of Fixed Tilt and Tuned Waveforms in Right-sided Implants

NCT00873691 | Completed

• 1 other identifier: CRD 442
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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 patients with right-sided implants.

Conditions

Healthy

Keywords

Patients indicated for an ICD/ CRT-D

Outcome Measures

Primary Outcomes (1)

• True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)

  Baseline

Secondary Outcomes (1)

• True DFTs in fixed tilt and tuned waveforms obtained in joules (J)

  Baseline

Study Arms (2)

1

ICD shocks programmed to Tuned Waveform

Device: ICD

2

ICD shocks programmed to 50% Tilt waveform

Device: ICD

Interventions

ICD DEVICE

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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with approved ICD/CRT-D indications

You may qualify if:

• 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

You may not qualify if:

• Patient is pregnant.
• Patient is less than 18 years old.
• SVC coil was turned ON during DFT testing

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Varma N, Efimov I. Right pectoral implantable cardioverter defibrillators: role of the proximal (SVC) coil. Pacing Clin Electrophysiol. 2008 Aug;31(8):1025-35. doi: 10.1111/j.1540-8159.2008.01130.x.

  PMID: 18684259 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.2007.00624.x.

  PMID: 17302691 BACKGROUND

• Varma N, Schaerf R, Kalbfleisch S, Pimentel R, Kroll MW, Oza A. Defibrillation thresholds with right pectoral implantable cardioverter defibrillators and impact of waveform tuning (the Tilt and Tune trial). Europace. 2017 Nov 1;19(11):1810-1817. doi: 10.1093/europace/euw306.

  PMID: 27986795 DERIVED

Study Officials

• Niraj Varma, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

US (1)