'Effect of CRT on Defibrillation Threshold Estimates' Study

NCT00626093 | Completed Phase 4 Results

• 1 other identifier: CRD 388
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this prospective study is to evaluate the effect of cardiac resynchronization therapy (CRT) on the defibrillation threshold (DFT) estimates in cardiac resynchronization therapy defibrillators (CRT-D) patients. The hypothesis of the study is that defibrillation threshold (DFT) will decrease with 6 months of cardiac resynchronization therapy (CRT).

Conditions

Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months

  All patients underwent defibrillation threshold testing at cardiac resynchronization therapy-defibrillator (CRT-D) implant and then at 6 months. The outcome measure is the difference in DFT (defibrillation threshold) in volts between implant and 6 months.

  Baseline and 6 months

Secondary Outcomes (1)

• Defibrillation Threshold Difference Obtained in Joules (J)

  Baseline and 6 months

Study Arms (1)

Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

OTHER

Patients in the study who received a Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for it. It's a single arm study in which patients underwent defibrillation threshold (DFT) testing at implant and 6 months.

Device: Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

Interventions

Cardiac Resynchronization Therapy - Defibrillator (CRT-D) DEVICE

* Patients in the study who receive Cardiac Resynchronization Therapy - Defibrillator (CRT-D) are indicated for Cardiac Resynchronization Therapy (CRT). * Patient undergoes Defibrillation threshold (DFT) testing at implant and at 6 months. Defibrillation threshold (DFT) testing will include 3 ventricular fibrillation (VF) inductions.

Also known as: Epic HF,Atlas+ HF,Epic II HF,Atlas II HF,Promote CRT-D

Cardiac Resynchronization Therapy - Defibrillator (CRT-D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meets standard indications for a Cardiac Resynchronization Therapy - Defibrillator (CRT-D).
• Patient will be implanted with an FDA approved St Jude Medical (SJM) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and compatible defibrillation lead system.
• Patient is able to tolerate defibrillation threshold (DFT) testing.
• Patient is geographically stable and willing to comply with the required follow-up schedule.
• Patient has a life expectancy of greater than 6 months from the time of implant.
• Patient has stable heart failure (HF) medications at least one month prior to enrollment.

You may not qualify if:

• Inability to successfully implant an intravascular lead Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device. (i.e. exclude epicardial leads).
• Patient is getting his Cardiac Resynchronization Therapy - Defibrillator (CRT-D) device replaced.
• Inability to successfully obtain the defibrillation threshold (DFT) at implant.
• Currently participating in a clinical trial that includes an active treatment arm or another data collection registry.
• Recent (within 24 hours) administration of Nesiritide™.
• Patient is on amiodarone (other antiarrhythmic agents known to affect defibrillation thresholds - DFTs) at the time of enrollment.
• Patient is pregnant.
• Patient is less than 18 years old.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

Penrose Hospital

Colorado Springs, Colorado, 80907, United States

Location

Related Publications (1)

• Gold MR, Hedayati A, Alaeddini J, Payne JP, Bailin S, Sturdivant JJ, Pradhan S, Oza AL. Temporal stability of defibrillation thresholds with cardiac resynchronization therapy. Heart Rhythm. 2011 Jul;8(7):1008-13. doi: 10.1016/j.hrthm.2011.02.006. Epub 2011 Feb 9.

  PMID: 21315841 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ashish Oza
• Organization: St. Jude Medical

aoza@sjm.com

818-493-3648

Study Officials

• Amir Hedayati, MD

  Glendale Heart Institute

  PRINCIPAL INVESTIGATOR

• Michael Gold, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 29, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 5, 2019
• Results First Posted: January 21, 2013

Record last verified: 2019-02

Locations

US (2)