Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

NCT00187200 | Completed Phase 4 Results

• 1 other identifier: CRD299
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the benefit of interventricular (V-V) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate. For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:

• \< 10% improvement in 6-minute hall walk, and
• no class improvement or worsening in New York Heart Association (NYHA) scale. For those receiving CRT-D devices as replacements of older CRT-D systems, patients are considered non-responders if BOTH of the following requirements are fulfilled:
• \> 1 heart failure (HF) related hospitalization, and
• no class improvement or worsening in NYHA scale.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• CRT Responder Rate

  Patients underwent baseline NYHA class and 6-minute hall walk distance (6-MHWD) assessment. After device implantation AV delays were optimized and all patients were programmed to simultaneous biventricular (BiV) pacing. At the 3-month follow-up, the NYHA class and 6-MHWD were reassessed. Non-responders were randomized 1:1 to either sequential BiV pacing with VV optimization or simultaneous BiV pacing. The responder rate at 6 months post randomization was compared between the two groups. Which is why the numbers are broken further down in the Outcome Measure table.

  6 months

Secondary Outcomes (3)

• NYHA Class Progression

  6 months

• 6 Minute Hall Walk Distance Test (6-MHWD)

  6 months

• Left Ventricular Ejection Fraction (LVEF)

  Randomization and 9 months

Study Arms (2)

Simultaneous VV Pacing

ACTIVE COMPARATOR

Programmed to simultaneous biventricular pacing

Device: Simultaneous VV Pacing

Sequential VV Pacing

ACTIVE COMPARATOR

Programmed to sequential biventricular pacing

Device: Sequential VV Pacing

Interventions

Simultaneous VV Pacing DEVICE

Right ventricular and left ventricular pacing delivered simultaneously.

Simultaneous VV Pacing

Sequential VV Pacing DEVICE

Right ventricular and left ventricular pacing delivered sequentially.

Sequential VV Pacing

Eligibility Criteria

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

You may qualify if:

• Patient has a standard indication for a CRT-D.
• Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath.
• Patient is geographically stable and willing to comply with the required follow-up schedule.
• Prior to 1 month of randomization, patient's HF medications are maintained stable and remain stable throughout the study.
• Patients requiring a CRT-D replacement must comply with BOTH of the following:
• \> 1 HF related hospitalization
• No class improvement or worsening in NYHA scale

You may not qualify if:

• Patient's life expectancy is less than 12 months.
• Patient has had cardiac surgery within 6 months of enrollment.
• Patient has an epicardial ventricular lead system.
• Patient is less than 18 years old.
• Patient is pregnant.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Due to the lower than expected non-responder rate at 3 months, the study did not reach the target randomized sample size.

Results Point of Contact

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

aoza@sjm.com

(818) 493-3648

Study Officials

• Raul Weiss, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 5, 2019
• Results First Posted: September 25, 2015

Record last verified: 2019-02

Locations

US (1)