Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

NCT00356057 | Terminated Results

• 1 other identifier: G040150
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

Conditions

Atrial Fibrillation; Congestive Heart Failure

Keywords

atrial fibrillation; AV node ablation; pacemaker; congestive heart failure

Outcome Measures

Primary Outcomes (3)

• Average Percentage Improvement From Baseline of the 6-minute Walk Test Distance and Minnesota Living With Heart Failure Quality of Life Score at 6-months

  Combined, average percentage improvement in 6-minute walk test distance and Minnessota Living With Heart Failure Quality of Life score from baseline to 6-month follow-up for the Protos DR/CLS (Group 1) and Stratos LV (Group 2) compared with the active control (Group 3). The 6-minute walk test is a test that measure how far a patient can walk in 6 minutes in a standardized walking course. Percent Change (0% (worst)-100% (best))

  Change from baseline to six months post-procedure

• Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure

  Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications.

  At six months post-procedure

• Number of Participants Free of System-related Complications (Related to the Device, Leads, or Implant Procedure) at 6 Months Post-procedure

  Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence. This endpoint evaluated system-related complications. All Stratos systems (in both the biV and RV pacing arms) were evaluated together as pre-specified in the protocol.

  At six months post-procedure

Secondary Outcomes (10)

• Change in Six-minute Walk Test

  Change from baseline to 6 months post-procedure

• Change in Quality Of Life (QOL) Score Over 6 Months Calculated as QOL Score at Baseline - QOL Score at 6 Months

  Change from baseline to six months post-procedure

• Cardiac Remodeling Assessments by Echocardiography - Change in Left Ventricular Ejection Fraction

  Change from baseline to six months post-procedure

• Changes in New York Heart Association (NYHA) Classification

  Change from baseline to six months post-procedure

• Percentage of Patients With Congestive Heart Failure (CHF) Related Hospitalizations

  At six months post-procedure

Study Arms (3)

1

ACTIVE COMPARATOR

Biventricular pacing group with Closed Loop Stimulation rate adaptation (Protos CLS device)

Device: Protos DR/CLS and Stratos LV CRT pacemakers

2

ACTIVE COMPARATOR

Biventricular pacing group with accelerometer based rate adaption (Stratos LV device)

Device: Protos DR/CLS and Stratos LV CRT pacemakers

3

ACTIVE COMPARATOR

Right Ventricular pacing group with accelerometer based rate adaption (Stratos LV device)

Device: Protos DR/CLS and Stratos LV CRT pacemakers

Interventions

Protos DR/CLS and Stratos LV CRT pacemakers DEVICE

Protos DR/CLS is a dual chamber pacemaker with CLS rate adaption, Stratos LV is a biventricular pacemaker with accelerometer based rate adaption

Also known as: Protos DR/CLS dual chamber pacemaker

1; 2; 3

Eligibility Criteria

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

You may qualify if:

• Meet the indications for therapy
• Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.
• Eligible for AV nodal ablation and permanent pacemaker implantation
• NYHA Class II or III heart failure
• Age ≥ 18 years
• Understand the nature of the procedure
• Ability to tolerate the surgical procedure required for implantation
• Give informed consent
• Able to complete all testing required by the clinical protocol
• Available for follow-up visits on a regular basis at the investigational site

You may not qualify if:

• Meet one or more of the contraindications
• Have a life expectancy of less than six months
• Expected to receive heart transplantation within six months
• Enrolled in another cardiovascular or pharmacological clinical investigation
• Patients with an ICD, or being considered for an ICD
• Patients with previously implanted biventricular pacing systems
• Patients with previously implanted single or dual chamber pacing system with \> 50% documented ventricular pacing
• Patients with previous AV node ablation
• Six-minute walk test distance greater than 450 meters
• Any condition preventing the patient from being able to perform required testing
• Presence of another life-threatening, underlying illness separate from their cardiac disorder
• Conditions that prohibit placement of any of the lead systems

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (10)

University of Alabama

Birmingham, Alabama, United States

Location

Lake Charles Memorial

Lake Charles, Louisiana, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Location

St. Joseph Mercy

Ann Arbor, Michigan, United States

Location

McLaren Heart Foundation

Lapeer, Michigan, United States

Location

NYU Medical Center

New York, New York, United States

Location

Aultman Hospital

Canton, Ohio, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

Spartanburg Regional

Spartanburg, South Carolina, United States

Location

Lone Star Arrhythmia

Amarillo, Texas, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due lack of enrollment.

Results Point of Contact

• Title: Katerina de Metz, Director Clinical Studies
• Organization: BIOTRONIK, Inc.

katerina.demetz@biotronik.com

5036752169

Study Officials

• Michael Orlov, MD

  Caritas Elizabeth, Boston, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 25, 2006
• Study Start: December 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 27, 2018
• Results First Posted: July 8, 2011

Record last verified: 2018-01

Locations

US (10)