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REmodeling the Left Ventricle With Atrial Modulated Pacing (REVAMP)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elevated night pacing on
Elevated night pacing off
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 NYHA Class II or III Heart Failure
  • Subject has had a prior Echo in past 6 months with: 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

Exclusion Criteria:

  • Subject has permanent AF or AF noted on baseline interrogation rhythm strip
  • Subject has uncontrolled BP; (systolic pressure needs to be >100mmHg and <160mmHg 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 meets any exclusion criteria required by local law
  • 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

Sites / Locations

  • University of Arizona - Sarver Heart Center
  • St Joseph's Medical Center
  • Northwestern University
  • University of Minnesota Medical Center Fairview
  • Lourdes Cardiology Services
  • The Lindner Research Center
  • The Ohio State University Wexner Medical Center
  • Lancaster General Hospital
  • Medical University of South Carolina (MUSC)
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Elevated night pacing on

Elevated night pacing off

Arm Description

Outcomes

Primary Outcome Measures

Participant's Ability to Tolerate Therapy
Participant's Ability to Tolerate Night Heart Pacing. The outcome of interest is the proportion of subjects who remain in the study. Study exit reasons will include intolerable symptoms, increase in NT-proBNP levels, decrease in LVEF or increase in troponin. The proportion of subjects remaining in study will be calculated along with the lower bound of the one-sided 95% confidence interval.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2017
Last Updated
April 16, 2021
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT03210402
Brief Title
REmodeling the Left Ventricle With Atrial Modulated Pacing
Acronym
REVAMP
Official Title
REmodeling the Left Ventricle With Atrial Modulated Pacing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elevated night pacing on
Arm Type
Active Comparator
Arm Title
Elevated night pacing off
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Elevated night pacing on
Intervention Description
Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
Intervention Type
Device
Intervention Name(s)
Elevated night pacing off
Intervention Description
Device will be programmed to normal lower rates
Primary Outcome Measure Information:
Title
Participant's Ability to Tolerate Therapy
Description
Participant's Ability to Tolerate Night Heart Pacing. The outcome of interest is the proportion of subjects who remain in the study. Study exit reasons will include intolerable symptoms, increase in NT-proBNP levels, decrease in LVEF or increase in troponin. The proportion of subjects remaining in study will be calculated along with the lower bound of the one-sided 95% confidence interval.
Time Frame
Baseline through 12 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 NYHA Class II or III Heart Failure Subject has had a prior Echo in past 6 months with: 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 Exclusion Criteria: Subject has permanent AF or AF noted on baseline interrogation rhythm strip Subject has uncontrolled BP; (systolic pressure needs to be >100mmHg and <160mmHg 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 meets any exclusion criteria required by local law 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Steinhaus, MD
Organizational Affiliation
Medtronic CRHF
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona - Sarver Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
Country
United States
Facility Name
St Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204-6019
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2969
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043-4322
Country
United States
Facility Name
The Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2906
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8905
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2717
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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REmodeling the Left Ventricle With Atrial Modulated Pacing

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