Optimal Pacing Rate for Cardiac Resynchronization Therapy

NCT06445439 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00006952
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective, randomized crossover study. The objective of the study is to determine if a pacing rate of 80 beats per minute (bpm) improves exercise tolerance during the 6-minute walk test. The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Conditions

Atrial Fibrillation, Persistent

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance as measured by the Six-Minute Walk Test

  Exercise tolerance as measured by the Six-Minute Walk Test

  3 months

Secondary Outcomes (12)

• Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire

  3 months

• Function as measured by the International Physical Activity Questionnaire

  3 months

• Change in B-type natriuretic peptide (BNP)

  3 months

• Change in creatinine

  3 months

• Change in New York Heart Association Class

  3 months

Study Arms (2)

60 bpm, then 80 bpm

EXPERIMENTAL

Pacing rate of 60 bpm for the first 3 months, then switch to 80 bpm for the next 3 months.

Device: Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm

80 bpm, then 60 bpm

EXPERIMENTAL

Pacing rate of 80 bpm for the first 3 months, then switch to 60 bpm for the next 3 months.

Device: Pacing rate of 80 bpm; Device: Pacing rate of 60 bpm

Interventions

Pacing rate of 80 bpm DEVICE

Pacing rate of 80 bpm

60 bpm, then 80 bpm; 80 bpm, then 60 bpm

Pacing rate of 60 bpm DEVICE

Pacing rate of 60 bpm

60 bpm, then 80 bpm; 80 bpm, then 60 bpm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• History of persistent or permanent atrial fibrillation
• Implantation of CRT or conduction system pacing in prior 3 months to 5 years of study start
• History of intrinsic AVN block or have undergone AVN ablation in prior 3 months to 5 years of study start
• LVEF ≥ 50%
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) \>400 pg/mL in the last 24 months
• Clinical HF diagnosis or NYHA class II or higher
• Able to provide informed consent

You may not qualify if:

• LVEF \<50%
• Wide QRS (greater than 150ms)
• Isolated RV pacing
• Severe valvular disease
• Severe coronary artery disease as defined by one of the following:
• ACS or PCI within 1 year
• Any angina (CCS class 1+)
• Unrevascularizable severe CAD (\>70% stenosis in 1+ major vessels and/or based on functional assessment)
• ESRD
• Significant primary pulmonary disease on home oxygen
• Major orthopedic issues, such as being wheelchair bound and/or unable to perform a six-minute walk test
• Ventricular ectopy \>15% premature ventricular contractions (PVC)
• End stage cancer diagnosis
• Life expectancy less than one year
• Palliative or hospice care

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Medtronic: collaborator

Study Sites (5)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

NOT YET RECRUITING

MedStar Southern Maryland Hospital

Clinton, Maryland, 20735, United States

RECRUITING

MedStar Heart and Vascular Office at Fairfax

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Athanasios Thomaides, MD

  MedStar Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarahfaye Dolman

CONTACT

302-530-1873; Sarahfaye.F.Dolman@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will randomly assign half of the participants to a starting rate of 60 bpm and then switch them to a rate of 80 bpm for 3 months, and vice versa.

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: June 6, 2024
• Study Start: December 19, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)