NCT01913613

Brief Summary

The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable heart-failure

Geographic Reach
10 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

July 30, 2013

Last Update Submit

July 13, 2020

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • MACCE

    subjects who experience major adverse cardiac and cerebrovascular events (MACCE) defined as death, stroke, MI; or subjects who experience a systemic embolic event (excluding pulmonary thromboembolism)

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the IASD device

Device: IASD

Interventions

IASDDEVICE

IASD device implantation

Treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
  • New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
  • One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
  • On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
  • Age ≥ 40 years old
  • Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
  • Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
  • PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
  • PCWP during supine bike exercise ≥ 25mm Hg, and CVP \< 20 mm Hg

You may not qualify if:

  • \. Severe heart failure defined as:
  • ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
  • Fick Cardiac Index \< 2.0 L/min/m2
  • Requiring inotropic infusion (continuous or intermittent) within the past 6 months
  • Patient is on the cardiac transplant waiting list 4. Inability to perform 6 Minute Walk Test 5. Known significant coronary artery disease (stenosis \>70%) 6. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months 7. Known severe carotid artery stenosis (\> 70%) 8. Presence of significant valve disease defined by echocardiography as: a) Mitral valve regurgitation defined as grade \>2+ MR b) Tricuspid valve regurgitation defined as grade ≥ 2+ TR; c) Aortic valve disease defined as ≥ 2+ AR or moderate AS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

The Prince Charles Hospital

Brisbane, Australia

Location

David Kaye

Melbourne, Australia

Location

St. Vincent Hospital

Sydney, Australia

Location

Medizinische Universität Graz

Graz, Austria

Location

Allgemeines Krankenhaus Univesitäts Kliniken

Vienna, Austria

Location

OLVZ Aalst

Aalst, Belgium

Location

Homolka Hospital

Prague, Czechia

Location

Rigshospitalet

Copenhagen, Denmark

Location

CHRU de Lille

Lille, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital Bichat

Paris, France

Location

Hôpital La Pitié Salpétrière

Paris, France

Location

Hôpital Rangueil

Toulouse, France

Location

Universitatklinikum Duseldorf

Düsseldorf, Germany

Location

Georg-August-Universitat

Göttingen, Germany

Location

Asklepios Klinik St George

Hamburg, Germany

Location

Cardiologicum CRC

Hamburg, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

Universtitaät Kliniku Schlewig Holstein

Kiel, Germany

Location

Klinikum der Universität Munchen

Munich, Germany

Location

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Fourth Military Hospital

Wroclaw, Poland

Location

Golden Jubilee Hospital

Glasgow, United Kingdom

Location

Royal Brompton/Harefield Trust

Harefield, United Kingdom

Location

King's College

London, United Kingdom

Location

Related Publications (8)

  • Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.

    PMID: 26055211BACKGROUND

  • Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.

    PMID: 27025436RESULT

  • Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.

    PMID: 27852653RESULT

  • Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.

    PMID: 28949052RESULT

  • Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.

    PMID: 30311437RESULT

  • Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.

    PMID: 30354556RESULT

  • Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.

    PMID: 31653352RESULT

  • Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.

    PMID: 31753198DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jan Komtebedde, DVM

    Corvia Medical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

July 1, 2018

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

FR(5)DE(7)GB(3)AU(3)BE(1)PL(1)CZ(1)NL(1)DK(1)NZ(1)