REmodeling the Left Ventricle With Atrial Modulated Pacing

NCT03210402 | Completed Results FDA Device

• 1 other identifier: REVAMP
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 10

Brief Summary

New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Remained on Study

  REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.

  Baseline through 12 week follow-up

Study Arms (2)

Elevated night pacing on

ACTIVE COMPARATOR

Device: Elevated night pacing on

Elevated night pacing off

PLACEBO COMPARATOR

Device: Elevated night pacing off

Interventions

Elevated night pacing on DEVICE

Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times

Elevated night pacing on

Elevated night pacing off DEVICE

Device will be programmed to normal lower rates

Elevated night pacing off

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 3 months
• Subject is stable on current medications
• Subject has dyspnea with exertion or diagnosed as New York Heart Association (NYHA) Class II or III Heart Failure
• Subject has had a prior Echo in past 6 months with: Ejection Fraction (EF) ≥ 50% and Diastolic volume \<80 ml/m²
• Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women 95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall thickness \>0.42, or Wall Thickness\>1.2cm (posterior wall)
• Subject is willing to sign and date the study Informed Consent Form (IC Form) - Subject is 18 years of age or older, or of legal age to give informed consent per local law
• Subject is expected to remain available for follow-up visits

You may not qualify if:

• Subject has permanent atrial fibrillation (AF) or AF noted on baseline interrogation rhythm strip
• Subject has uncontrolled BP; (systolic pressure needs to be \>100 mmHg and \<160 mmHg on medications)
• Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0 cm² or severe regurgitation of the aortic or mitral valve
• Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen
• Subject's Pacemaker has less than 6 months of Pacemaker battery life
• Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9 months prior to enrollment
• Subject's programmed upper rate limit is less than 100 bpm because of concerns of elevated pacing
• Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled study visits
• Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager)
• Subject is pregnant
• Subject's life expectancy is less than 12 weeks
• Subject with medical condition that precludes the patient from participation in the opinion of the investigator
• Subject has known coronary disease with Class II angina

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (10)

University of Arizona - Sarver Heart Center

Tucson, Arizona, 85724-0001, United States

Location

St Joseph's Medical Center

Stockton, California, 95204-6019, United States

Location

Northwestern University

Chicago, Illinois, 60611-2969, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043-4322, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219-2906, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425-8905, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-2717, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The study ended with fewer participants than was desired for the investigation. The study ended due to difficulty finding eligible patients.

Results Point of Contact

• Title: Mike Bennett, Clinical Study Manger
• Organization: Medtronic Inc

mike.s.bennett@medtronic.com

262-362-1956

Study Officials

• David Steinhaus, MD

  Medtronic CRHF

  STUDY DIRECTOR

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: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: July 6, 2017
• Study Start: September 15, 2017
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)